REPORT ON DRUG REGULATORY SYSTEM...

REPORT ON DRUG REGULATORY SYSTEM ASSESSMENT OF MONGOLIA

ULAANBAATAR 2011

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Abbreviations ................................................................................................................................................... 3

Acknowledgement ........................................................................................................................................... 4

Executive Summary .......................................................................................................................................... 5

1. General information on the assessment. ..................................................................................................... 7

1.1 Purpose of this assessment report......................................................................................................... 7

1.2 Objectives ............................................................................................................................................... 7

1.3 Place and date of the assessment .......................................................................................................... 7

1.4 Method ................................................................................................................................................... 7

1.5 Members of the assessment .................................................................................................................. 8

2. General information on the country ............................................................................................................ 8

3. Findings ........................................................................................................................................................ 9

3.1. Legislation ............................................................................................................................................. 9

3.2 Regulatory functions .............................................................................................................................. 9

3.2.1 Funding .......................................................................................................................................... 11

3.2.2. Infrastructure ............................................................................................................................... 11

3.2.3 Human resource management ..................................................................................................... 11

3.2.4 Quality management system ........................................................................................................ 11

3.2.5 Impartiality, transparency and accountability .............................................................................. 12

3.2.6 Information management systems and Communication activities .............................................. 12

3.3 Medicines registration (marketing authorization) ......................................................................... 13

3.4. Licensing of activities of pharmaceutical establishments ................................................................... 16

3.5. Registration of Pharmacy personal ..................................................................................................... 18

3.6. Import and export control .................................................................................................................. 19

3.7. Market surveillance ............................................................................................................................. 19

3.8 Control of Drug Promotion and Advertising ........................................................................................ 20

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3.9 Pharmacovigilance ............................................................................................................................... 21

3.10 Control of Clinical Trials ..................................................................................................................... 23

3.11 Regulatory inspection and enforcement activities ............................................................................ 25

3.12 Quality Control Laboratory ................................................................................................................ 28

3.13 Control of Narcotics, Psychotropic Substances and Precursors ......................................................... 28

3.14 International Cooperation and Harmonization .................................................................................. 32

4. Conclusions and Recommendations .......................................................................................................... 33

Annex 1 Assessment tool ............................................................................................................................... 36

Annex 2 List of organizations visited and list of persons met ...................................................................... 76

Annex 3 References: ...................................................................................................................................... 78

Annex 4. Quantitative indicators for regulatory purposes ............................................................................ 80

Annex 5 Organogram of Drug Regulatory organizations of Mongolia ........................................................... 84

Annex 6 Action plan ..................................................................................................................................... 85

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Abbreviations

ADB Asian Development Bank ADR Adverse drug reaction API Active pharmaceutical ingredient BP British Pharmacopoeia CT Clinical trial DOH Department of Health GASI General Agency for Specialized Inspection GCP Good clinical practices GDP Good distribution practices GLP Good laboratory practices GMP Good manufacturing practices GXP Good practices HMO Health Minister’s Order HSUM Health Sciences University of Mongolia ICH International Conference for Harmonization IEC Independent ethics committee IRB Institutional review board KFDA Korean Food Drug Administration MA Market authorization MAH Market authorization holder MCA Millennium Challenge Account MEC Medical Ethics Committee MOH Ministry of Health MNS Mongolian National Standard NDCL National drug control laboratory NGO Non-governmental organization NMRA National Medicine Regulatory Authority NPSP Narcotics, psychotropic substances and precursor chemicals NRA National Regulatory Authority OTC Over the counter PI Product information PPC Pharmacy Professional Committee QMS Quality management system SPC Summary of product characteristics WHO World Health Organization

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Acknowledgement

This Drug regulatory assessment of Mongolia was assigned by the Ministry of Health

and completed with the financial and technical support from the World Health

Organization

We would like to acknowledge with gratitude the contribution of all people who

participated representing the following institutions and associations:

Division of Pharmaceuticals and Medical Devices, Ministry of Health of Mongolia,

Division of Drug regulation, Health Department-Implementing Agency of the

Government Mongolia, and Human Drug Council of Mongolia, Ministry of Health of

Mongolia

Health and Education Monitoring Office, Professional Inspection Agency-Regulatory

Agency of the Government of Mongolia,

Central Laboratory, Professional Inspection Agency-Regulatory Agency of the

Government of Mongolia,

Drug Reference Laboratory,

Quality Control Laboratory of Pharmacy School, Health Sciences University of

Mongolia,

The Regulatory Agency for Fair Competition and Consumer Protection and

Criminal Police Department of Mongolia.

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Executive Summary

This assessment was commissioned by the Ministry of Health of Mongolia, Health

Sector Development Project 4 by Asian Development Bank and Word Health

Organization. It aims to assess the legal basis, structure, procedures and

implementation of drug regulation in Mongolia including registration, inspections and

enforcement, licensing, clinical trial, market, import and export control, drug

advertisement and promotion controls, pharmacovigilance, and control of narcotics

and psychotropic substances. The assessment was conducted using the WHO Data

Collection Tool for the Review of Drug Regulatory Systems.

The drug regulatory activities gained many successes and benefits during recent

years. Drug regulatory legislation is mainly based on The National Drug Policy, the

Law on Drug and Medical Devices, and on the Law on Health. The government and

international organizations support specific actions towards the implementation of the

National Drug Policy, and its strategies were undertaken. Some regulatory activities,

such as registration and import authorization are relatively stable, and the online

system “Licemed” for drug registration, licensing and special permissions is

established. Most of the drug regulatory activities are organized according to the legal

and regulatory papers based on WHO guidelines. The Drug Regulation Division of

DOH is established as a National Medicines Regulatory Authority (NMRA) and has

started its operations. One of the notable steps is that the first edition of a Mongolian

Pharmacopeia has been published.

However, there is still a gap for further improvement. Drug regulatory functions are

undertaken by different organizations such as the Division of Drug Regulation of

Department of Health, Government Implementing Agency for Health and Education

Division of State General Agency for Specialized Inspection. Although it was

explained that DOH is mainly responsible for internal regulations, and GASI conducts

external inspection actions, there is still a lack of efficient cooperation and exchange

of information between these organizations.

The legal provisions for some of the regulations are missing: market surveillance and

pharmacovigilance programmes need to be defined; drug promotion and advertising

elements should be clarified according to international standards; drug promotion

activities organized by medical representatives and distributors should be controlled.

As the Drug Regulatory Division of Department of Health was only recently

established, its human resources should be strengthened, and more staff needs to be

recruited. The staff training needs should be assessed, and training should be

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conducted according to the needs defined with cooperation of national and

international training organizations.

Moreover, DOH should improve its transparency by having an internal policy on

potential conflicts of interest for staff members; a model format for a declaration of

conflicts of interest for staff and experts; and mechanisms to recognize conflicting

interests and manage them appropriately. Also, DOH should be more open to the

public and improve its information distribution and publicity.

Drug and other health products advertisement activities to the public have started to

be controlled and assessed to some extent; an advertisement permission procedure

has been introduced, and was reviewed by the Pharmacology Sub Committee of

Human Drug Counsel. However, there is a room for further improvement on drug

promotion and capacity should be built at DOH, State Inspectorate Agency, and The

Unfair Competition and Consumer Rights Protection Regulatory Agency

The issues of clinical trials and other biomedical research activities are mainly

managed by the Medical Ethics Committee. However, there is a lack of cooperation

between the Medical Ethics Committee and Drug and Medical Devices Division of

MOH, Drug Regulatory Division of DOH, and GASI; information sharing mechanisms;

limited participation of the drug organizations; and lack of drug related guidelines.

There are 3 state laboratories to perform quality control testing of pharmaceutical

products. Currently, the Drug and Bio Preparation Unit in the Central Laboratory of

GASI is the main laboratory, and conducts quality control testing of the pharmaceutical

products in the country. The other two laboratories, at the Health Science University

and at the Public Health Institute, are performing tests within the limited area for the

contracted organizations. Currently those laboratories cannot carry out proper quality

control of pharmaceutical products. The capacity of those laboratories needs to be

improved in terms of human resources, equipment and maintenance.

The implementation and enforcement of legal and regulatory papers is very weak, and

action needs to be taken.

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1. General information on the assessment.

1.1 Purpose of this assessment report

This report aims to give an overview of the legal basis, structures, processes and

implementation of medicines regulation in Mongolia. It is anticipated that it will help

policy makers, funders and other interested stakeholders to better understand the

situation and to design appropriate actions to strengthen regulatory systems in

Mongolia.

1.2 Objectives

The objectives of this report are:

• to highlight the main strengths and weaknesses of medicines regulation in

Mongolia;

• to put the findings into the context of the global regulatory situation and of

internationally recommended standards for effective medicines regulation;

• to provide a baseline and perspective for future assessment strategies.

1.3 Place and date of the assessment

The assessments summarized in this report were conducted during visits to NMRAs

Mongolia in November to December 2011.

1.4 Method

This assessment conducted according to Drug Regulatory Assessment Tool

developed by WHO. Written terms of reference and an agenda for the visits were

agreed beforehand with the regulatory authority being assessed. The duration of the

visits varied depending on the complexity of the regulatory functions, most visits took

approximately two to three working days.

Data were collected by interviewing personnel, reviewing documents (manuals,

records, reports, and files), analyzing data and/or observing activities. Findings were

recorded on a comprehensive drug regulatory assessment tool sheet. The draft report

was submitted to the regulatory authority after the visit together with a draft plan of

action, and comments were invited.

This summary report was produced mainly on the basis of the reports provided to the

NMRAs assessed. The completed data collection tools were consulted to verify and

complete the findings where necessary.

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1.5 Members of the assessment

This assessment commissioned by MOH Mongolia and conducted with financial

support of WHO. The assessments were conducted by teams composed of external

consultants Dr. Purevsuren Sodnomtseren Ph.D, lecturer of School of Pharmacy,

HSUM and Ms. Munkhdelger Byambaa MBA , Em Association. It was supervised and

consulted by Dr. Munkhdelger Chimedtseren, Head of Pharmaceuticals and Medical

Devices Division, Ministry of Health.

2. General information on the country

The territory of Mongolia is located in the central part of Asia between 41°35-52°06 of

attitude and 87°47-119°57 of longitude, neighbouring with Russian Federation along

3543 km in the north and with Peoples Republic of China 4709.6 km in the south. At

1.564,116 km2 (603,909 mi²), Mongolia is the world's 19th-largest country in the

world.

The total population of Mongolia in 2010 was 2 780 757 with an annual population

growth rate of 1.70% i. The annual GDP growth rate is 1.25 %. Some economic

indicators are shown in table 1. Table 1. Economic indicators in 2010

Indicators 2010

Annual change of GDP, % 6.1

GDP per capita, thousands MNT 3,001,463.23

GDP per capita, USD 2,226.98

Inflation rate, annual average % 10.1

General government revenue, bn. MNT 3,073.31

Exchange rates, annual average, MNT/USD 1357.84

Exchange rates, annual average, MNT/EUR 1805.08

Exports, mln.USD 2899.2

Imports, mln.USD 3277.9

Source: Mongolian Statistical yearbook. National Statistical Office of Mongolia, 2010

Table 2. Health indicators in 2010

Indicators 2010

Life expectancy at birth for men (Years) 64.93

Life expectancy at birth for women (Years) 72.26

Infant mortality rate, between birth and age 1 (/1.000 live births) 19.4

Under 5 mortality rate, (/1.000 live births) 24.6

Maternal mortality ratio, (100.000 live births) 45.5

Neonatal mortality rate (/1.000 live births) 11.6

Age-standardized mortality rate by cardiovascular diseases (100.000 population)

236.1

Age-standardized mortality rate by cancer (100.000 population) 130.2

Mortality rate for tuberculosis (/100.000 population) 3.3

Source: Health Indicators. Department of Health, Government Implementing Agency, 2010

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3. Findings

3.1. Legislation

The National Drug Policy of Mongolia (NDPM) was approved in December, 2002 by

the State Great Khural of Mongolia. The NDPM is an integrated part of the

Comprehensive Policy on the Mongolian National Security. The NDPM shall be

directed to provide health organizations, veterinary hospitals and people with highly

effective, qualified, registered drugs and medical equipments continually, sufficiently

and equally, and to introduce and promote appropriate use of drugs. The NDPM

consists of the areas covering the legislation, drug selection, manufacturing,

distributing, drug financing, drug quality assurance and rational use of drugs. The

Law on Drug and Medical Device of Mongolia has been revised totally three times,

after the 1st approval in 1998. Since then, several modifications have been

completed.

Law on Drug and Medical Device enacted by Parliament and Health Minister’s Order

N 278 provide for the establishment of a NMRA. NMRA performs its regulation

activity in the frame of Law on Drug and Medical Device, Law on State Inspection,

Law on Government Service, and Law on Government Agency.

Regulations provide details of how regulatory functions are to be carried out. Based

on the legislation, guidelines are needed to interpret the legislation and to advise on

how to comply with a regulation.

The legal framework should allow effective implementation and provide adequate

powers to the NMRA. Legislation covers all products for which medicinal claims are

made, as well as related manufacture and trade activities, in the public and private

sectors.

3.2 Regulatory functions

Regulatory activities are organized and performed at a central level of the country.

Drug regulatory functions are undertaken by different organizations which make

coordination difficult and create inefficiencies. Organizations involved in drug

regulation are:

- Pharmaceutical and Medical Devices Division, MOH

- Division of Drug Regulation, the Department of Health, Government

Implementing Agency

- Health and Education Division, General Agency for Specialized Inspection

(GASI)

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Pharmaceutical and Medical Devices Division, MOH is responsible for the policy

development on medicines and medical devices, drug registration, import

authorization, pharmacovigilance and and drug assurance are under the Government

Implementation Agency-Department of Health. The General Agency for Specialized

Inspection (GASI) is responsible for pharmaceutical inspection, border inspection,

and operations of the drug control laboratory. Decentralization and cooperation

between authorities is insufficient.

According to Health Minister’s Order 278/2011, Division of Drug Regulation,

Department of Health implements the following activities:

− Marketing authorization of drug and biologically active products;

− Post marketing surveillance;

− License of manufacturers, importers and distributors;

− Drug information, advertising;

− Drug assurance;

− GMP assessment;

− Development of standards and pharmacopeia monographs, monitoring

on the implementation;

− Monitoring, analysis and assessment of drug prescription and usage;

− Import and export authorization;

− Price regulation of drugs in EDL;

− Pharmacovigilance;

− Professional inspection

At the time of visit the activity of license of manufacturers, importers and distributors

are not performed by Division of Drug Regulation. Division of Medical Care was

responsible for this activity. Because the Division of Drug Regulation has been just

reformed, some activities were not performed by the time of visit. The activities of

Post marketing surveillance, GMP assessment, and Professional inspection were not

performed.

The NMRA has not established an Institutional Development Plan and action plan.

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3.2.1 Funding

The NMRA depends on government funding and with all fees paid directly to the

Ministry of Finance and not receives donor funding. Fees commonly charge for initial

marketing authorization, renewal and retention and drug assurance.

3.2.2. Infrastructure

According to Health Minister’s order 278/2011, 20 officers should work at the Division

of Drug Regulation, Department of Health. At the time of visit, there were 8 officers at

Division of Drug regulation, because the Division has been just organized. Key

personal for drug regulation are Vice Chairmen for Medicine and Head of Division of

Drug Regulation, and there is no scientific person. The work space, work

environment, equipment and support services are inadequate.

2 drug inspectors work at the Health and Education Division of the General Agency of

Specialized Inspection, Regulatory Agency of the Government.

3.2.3 Human resource management

An organization Chart for the NMRA staff is established and updated. The duties,

functions and responsibilities of the key personnel are established in the job

descriptions. The NRA has established the necessary competencies (education,

training, skill and experience) needed for the key personnel to perform the assigned

work. The selection of staff is performed by Government Service Counsel according

to Law on Government Service.

The NMRA has not human resource development plan. An initial and periodic staff

appraisal system is not established and there is no induction program for newly

recruited staff. The NMRA has no scientific advisor, and not involved in a global

network with relevant scientific associations and professional societies. Although the

NMRA takes advantage of external experts for registration and drug assurance and

involves them in its regulatory processes, there is no written policy for the recruitment

and the designation of external experts and members of experts committees calling

for candidates, defining the review by a selective jury, appointments and publishing of

the final decision, and to cross off. A contract between the NMRA and each external

expert defining roles and responsibilities was established and signed by both parties.

3.2.4 Quality management system

NMRA not implements a comprehensive QMS.

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3.2.5 Impartiality, transparency and accountability

NMRA had a website (www.doh.gov.mn) at the time of visit, but it was not functioning

correctly and it was not possible to get all information related to drug regulation

activity from this website.

Transparency of NMRA need be improved. There are no internal policy on potential

conflicts of interest for staff members and no model format for a declaration of

conflicts of interest for staff. There is no written policy for the recruitment and the

designation of external experts and members of experts committees calling for

candidates, defining the review by a selective jury/panel, appointments and

publishing of the final decision but also to cross off. Conflicting interests need to be

recognized and managed appropriately. To provide credible regulatory services,

NMRA must have specific measures in place to avoid conflict of interest in decision-

making, to ensure confidentiality, to make their rules and decisions, transparent and

to consult with stakeholders. Although there is documented Code of conduct for

members of Human Drug Counsel, but no code for staff members involved in drug

regulatory and experts.

Consultation with stakeholders takes place in Mongolia, although it tended to be

limited to specific issues (e.g. regulations) or groups (e.g. professional associations).

Current information was not always publicly available. Although the NMRA organizes

meetings with the key stakeholders and open days for the public, the industry,

consumers and patients’ representatives are not involved as observers in technical

committee meetings. The agendas of the technical committees are not published in

advance and the minutes of the meetings are not publicly available.

A competent contact person or a public relations unit is not established and known by

the interested parties. An annual report with the allocated budget mentioning the

origin of fund is not published on a periodic basis and is not publicly available.

The legislation not provides requirements for monitoring and accountability of the

NMRA by stakeholders. The regulatory processes are not reviewed in order to

identify problems, gaps and inconsistency within the regulatory authority.

3.2.6 Information management systems and Communication activities

Though the NMRA has its own website (www.doh.gov.mn), but it has not established

an integrated network of all computers related to regulatory functions. The NMRA

does not employ its own IT staff. The NMRA has not established a communications

strategy to maintain confidence in the regulations and a crisis plan for coping with

major incidents and information.

http://www.doh.gov.mn/


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3.3 Medicines registration (marketing authorization)

Authorization of medicines for sale in a country, based on a scientific assessment of

their safety, efficacy and quality, could be considered as the core regulatory function.

Legal basis and regulations

Law on Drug and Medical Devices requires marketing authorization (registration) for

all pharmaceutical products on the market however exceptions for registration exist.

Law on Drug and Medical Devices and Registration regulation enables the NMRA to

issue a marketing authorization for a pharmaceutical product, to suspend it for a

period of time and to withdraw it. Registration regulation approved by Health

Minister’s order N38, 2007 requires the applicants to demonstrate the quality, safety

and efficacy of the pharmaceutical product that is subject of the application. At the

time of this assessment draft on new registration regulation is on the discussion. Law

on Drug and Medical Devices has a provision which exempts some products (such as

orphan drug, donations and other products) from registration. Provisions for renewal

of marketing authorizations were in place, usually after 5 years. But there isn’t a legal

requirement for handling periodic reviews to MAs. Legal provisions do not require the

notification to the NMRA of any variations to the initial MA which may affect the

quality, safety and efficacy of the products. The legal provisions do not envisage the

case of demonstrated bioequivalence of multisource generic products with innovator.

18 provision of Law on Drug and Medical Devices specifies the information to be

provided with the products (packaging, labelling, leaflet, Summary of characteristics,

etc). There is no legal provision regarding the MA holder and manufacturer’s liability

for defective products.

Guidelines

The aim of the visits was not to verify compliance with WHO guidance systematically,

but rather to assess the adequacy of national guidelines and to identify gaps. Any of

the following guidelines were developed:

Guidelines on the content of Product Information Leaflets, Summary of

Product Characteristics (SPC), packaging and labelling.

Guidelines on the applicable requirements on various process

validation

Guidelines on the applicable requirements on analytical method

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Application requirement and format are on www.doh.gov.mn.

Organization and structure

Marketing authorization activities are organized and performed at a central level of

the country. Division of Medicine Regulation, Government Implementing Agency-

Department of Health, is responsible for marketing authorization. There should be 4

officers for registration and they are responsible for:

Registration of medicine;

Registration information;

Registration of biologically active products;

Registration of vaccine

Decision for registration is developed by Human Drug Council on the basis of expert

conclusion.

Assessment procedures

The product information, Summary of Product Characteristics (SPC), packaging and

labeling are indicated on LICEMED.

Timeframes for assessment of applications is 3 months. Fast-track mechanism is not

existed for products registered.

validation.

Guidelines on the applicable requirements on stability testing of

pharmaceutical products (API, finished products).

Guidelines on the applicable requirements to the demonstrate

bioequivalence/bioavailability.

Guidelines for applicants or their representatives on the content of the

application, the format and the procedures to follow in order to submit

an application for a MA.

Guidelines for marketing authorization holders defining the types and

scopes of variations, the format and the documentation required as

well as specifications of the variations that are subjected to prior

approval.

Guideline on drug donation.

Guidance on risk management programs, pre-marketing risk

assessment and development of pharmacovigilance plans


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Documented procedure is only implemented for decision-making and to issue the

marketing authorization in a standardized format. In other case the documentation is

not implemented.

Department of Health has not advisory committees and uses 38 pharmaceutical and

clinical experts for assessment procedures. Provisions for confidentiality and

declaration of interest were lacking. The manufacturer's or license holder's

representatives are registration experts and are involved in assessment work.

Different criteria are used for the evaluation of MA applications of imported, local,

traditional medicines and raw materials.

Each pharmaceutical product receives a unique identification number that appears on

the labeling, packaging and product information.

Although Division of Medicines Regulation uses regulatory decisions, reports or

information from other NMRAs or international bodies for decision making, external

information for decision making on the applications submitted are not readily

available.

Assessment procedure doesn’t cover cost-benefit and benefit-risk analysis

assessment. The risk management program and pharmacovigilance plan, internal

tracking system is not used in registration procedure.

Human and other resources

The job descriptions for the staff are defined. By the assessment time only 2 officers

work at Division of Medicine Regulation and officers for registration of biologically

active products and vaccine don’t work. There is no internal planning of human

resource utilization.

NMRA has an archive for documents, but no storage space for under the registration

files and equipment for MAs functions. There is no networked computerized system

designed for medicines registration in place.

Records and availability of information

There is no list of all the product applications received, approved, suspended or

withdrawn and of the applications refused. The NMRA retains a master file of each

registered product including the application, approved drug information, assessment

report, etc. Master files of refused products are given to applicants.

A list of all the registered approved products is established, updated, published and

made publicly available (LICEMED).

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A summary of the assessment report as a basis for decision-making is not published

officially and positive decision is publicly available. The decision is put on LICEMED,

www.doh.gov.mn and Journal of Drug Information. The list of all the licenses

withdrawn, suspended or refused is not published.

3.4. Licensing of activities of pharmaceutical establishments

NMRA is responsible for licensing of drug suppliers and manufacturers. Licensing of

pharmacies is not performed at center level of the country.


Mongolia has a system in place to license pharmaceutical establishments. The

legislation requires a company which manufactures and imports a pharmaceutical

product or an active pharmaceutical ingredient to hold a license. Law on Licensing,

Law on Health, Law on Drug and Medical Devices requires pharmacies and retail

outlets or prospective pharmacies and retail outlets of pharmaceutical products to

hold a license.

The legislation enables the NMRA issue a license for a manufacturer of

pharmaceutical products, an importer, an exporter and a distributor, pharmacies to

suspend it for a period of time and to withdraw it. There are no legal exemptions to

licensing requirements with defined criteria. Drug manufacturers, drug suppliers and

pharmacies should comply with MNS. Although legal requires that all drug

manufacturers should follow, there are no drug manufacturers with GMP certification

because no authority is responsible for GMP certification.

Guidelines

Only one guideline for GMP is developed and published for drug manufacturers.

Guidance based on the WHO model and its supplementary guidance provides

information on compliance with GMP requirements. Other guidelines needed for drug

manufacturers, drug suppliers and pharmacies are not available.

Organization and structure

Licensing activities for drug manufacturers and importers, distributers are organized

and performed at a central level of the country and Government Implementing

Agency- Department of Health is responsible for it. Although according to Health

Minister’s Order N278, license function should be performed by Division of Drug

Regulation under the Vice chairman for Drug affairs, by the time of this assessment


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this function was performed by Division of Medical Care under the Vice chairman for

Medical affairs. Activities to other agencies, authorities follow the Mongolian Laws,

standards and procedures.

Licensing activity for pharmacies are organized and performed by Health

Departments of provinces at local level and there is no central organization

responsible for pharmacies. Decentralization of licensing, involving regional

authorities was not organized efficiently. Lack of coordination between departments

and with enforcement agencies was highlighted.

Licensing assessment procedures

According to License Law the decision on license should be issued within 21 working

days since receiving the application. An internal tracking system is not established to

follow the targeted time. The same criteria are used for licensing regardless of the

affiliation. Documented procedure is implemented for decision-making and to issue

the license in a standardized format. In other case the documentation is not

implemented. A written license, signed by a person with the adequate delegation, is

sent to the applicant, including conditions or restrictions. Documented quality control

is not performed.


The job descriptions for the staff are defined. By the assessment time staff for

licensing of manufacturers and importers, distributors is not belonged to the Division

of Drug Regulation, DOH. 1 officer for drug affairs works at Health Department of

Ulaanbaatar and human resource is not enough for license function. There is no

internal planning of human resource utilization.

NMRA and Health Department of Ulaanbaatar have not enough storage space for

licensing files and equipment for licensing functions. There is no networked

computerized system designed for license.

Records and availability of information

There is a list of all licensed manufacturers, importers, distributors and pharmacies.

The NMRA retains a master file of each licensed manufacturers, importers and

distributors, including company, name and contact details, key personnel, address,

equipment, list of drugs manufactured, imported and supplied, and etc.

A list of all the pharmacies is publicly available (www.health.mn, Journal of Drug

Information).

http://www.health.mn/

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The list of all the licenses withdrawn, suspended or refused for manufacturers and

distributors is not published and is not publicly available.

3.5. Registration of Pharmacy personal


25th provision of Law on Health and Health Minister’s Order 280, 2011 require a

pharmacist and pharmaceutical technician should be registered by a Regulatory

Authority. According to Health Minister’s Order 135/2006, pharmacists and

pharmaceutical technicians perform their duties in accordance with a code of ethics of

the pharmaceutical profession. There are legal requirements defining the necessary

criteria that must be met regarding the pharmaceutical qualification and the

experience for a pharmacist and pharmaceutical technicians.

Pharmaceutical Professional Committee

Pharmaceutical Professional Committee was organized in 2008 by Health Minister’s

Order 252/2008. The composition of the PPC is clearly defined. The mission,

responsibilities and powers of the PPC are clearly defined and include in particular:

• The issuance of standards of practice and conduct,

• The setting of standards of education and training for pharmacists and pharmaceutical technicians.

Medical Ethics Committee

Medical Ethic Committee was established by Health Minister’s order 135, 2006. The

composition of the EC and the mission, responsibilities and the powers of MEC are

clearly defined on this order.

Guidelines and Registration procedures

There is no guideline on the content, the format of the applications and the procedure

to follow for the registration of pharmacists and pharmaceutical technician.

Documented procedures are implemented for assessing the applications for

registration and for issuing the licenses and renewal: as a pharmacist and

pharmaceutical technician. This procedure considers in particular a continual

professional education.

Organization and structure, human and other resources

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Registration of medical personal is organized and performed at a central level of the

country and Government Implementing Agency- Department of Health is responsible

for it. A mechanism of exchange of information was not established and implemented

in order for the decentralized organization to receive requests and directives from the

central authority and to report to it.

1 officer for the registration of medical person works at Division of Medical

Professional Development, DOH and human resource is not enough for license

function. There is no internal planning of human resource utilization.

Records and outputs and availability of information

Health net program was developed in 2009 by the funding from WHO and a list of all

registered pharmacists and technicians was available on this program. But it didn’t

work since 2010. The NMRA retains a file of each registered pharmacist and

pharmaceutical technician containing at least the following types of information:

name, place of exercise, diploma or qualification and contact details.

3.6. Import and export control

The legal provisions require the importer to hold an importing authorization before

organizing the importation activities. Before each importation, importers should hold

an import certification and the origin, name, formulation, dose, amount,

manufacturer’s name of the product, border name and importation period are

indicated on the import certification. The import license activities are organized and

performed at a central level of the country by the NMRA. This function was performed

by Ministry of Health and according to Health Minister’s Order N 343 this function has

been just transferred to NMRA by the assessment time. A system to grant marketing

authorization for pharmaceutical products is not in itself a sufficient mechanism to

control the quality of products circulating in the country. Control of imported products

is weak. Mechanism of exchange of information is weak. There was no efficient

system to verify the marketing authorization status and exemptions for imported

products. Cooperation of NMRA with police and customs is weak. No guidelines for

importers and exporters on the format and content of the application and the

procedure to follow for these authorizations.

3.7. Market surveillance

Because market surveillance is not developed in Mongolia, there is no market

surveillance strategy, program, and quality monitoring program. NMRA lacks a written

procedure to organize an effective recall.

20

3.8 Control of Drug Promotion and Advertising

In 2010 the Law on Drug and Medical Devices was amended by new article No 13 on

drug information and advertisement together with its enforcement points. Also the

Law on Advertisement has articles on regulation of information distribution related to

health and other health products. Those legal provisions are contributed to the

combating with the false information on drug and other health products and proper

use of the drugs. According to the Law on Drug and Medical Devices amendment, the

conditions and criteria for the advertisement of the pharmaceutical products to the

general public is defined, the advertisement activities for drug and other products

have been started to be controlled and assessed in some extent and capacity has

been building up at DOH, GASI and The Unfair Competition and Consumer Rights

Protection Regulatory Agency

According to the WHO definition "promotion" refers to all informational and

persuasive activities by manufacturers and distributors, the effect of which is to

induce the prescription, supply, purchase and/or use of medicinal drugs. Moreover

article No 26.3 of the Law on Drug and Medical Devices stated that the drug

information should be factual and substantial and independent from manufacturer and

distributor. Then drug promotion conducted by the medical and sales representatives

is considered as new drug information for the healthcare staff and credit hour

certificate is awarded for the attended healthcare staff. Up to date, there are about 60

medical representatives and 10 sales representative offices are conducting

promotional activities to improve the drug sales and prescription writing. So it could

be said this regulation of credit hour certificate award is against the above mentioned

Law article. Also there is another article No 11.1.6 of the law on Drug and Medical

Devices stated that drug wholesaler or distributor should prohibit the supply, offer or

promise to persons qualified to prescribe, to supply and to dispense the

pharmaceutical products any gift, pecuniary advantage or benefit of any kind unless

strict conditions are met. Also there is no existing legal provision in relation to free

distribution of drugs for the purpose of promotion, control of promotion activities

organized during scientific meetings and symposiums and criteria for the professional

knowledge level of person who is conducting drug promotion.

DOH has started to collect the application materials for advertisement permission.

The applications and submitted relevant materials for the drug advertising permission

are reviewed by the Pharmacology sub Committee of Human Drug Council, MOH.

The amendment of the Law on Drug and Medical Devices stated the permission

issues for not only drug advertisement but also for biologically active products and

supplements. As a result of enforcement activities, 13 non authorized biologically

21

active product promotions on TV and Radio were stopped by The Unfair Competition

and Consumer Rights Protection Regulatory Agency

However, there are some gaps in this area including non existence of legal provision

for some important elements, lack of clearly defined guidelines to keep the process

effective, transparent and open to the public, poor enforcement environment and lack

of human resource and other supports.

DOH activities in providing permission and authorization for the drug advertisement is

lacking of transparent manner. It does not maintain the updated database of the

authorization materials, sufficient information sharing and publication through its

website and other communication channels and control of the drug promotion content

for the healthcare staff. Therefore community involvement in controlling drug

promotion is really missing. There is no officially authorised independent reference

and information source about drug and materials in Mongolian is not sufficient.

Another challenging issue is lack of human resource and logistic supports. The

Pharmacology Sub Committee, which is responsible for review and assessment of

the submitted materials for drug advertising authorization, consists of only non-vacant

members and any external experts are not invited.

3.9 Pharmacovigilance

Legal basis

The issue of pharmacovigilance have been introduced to the country officially in 2003

when the relevant articles No 6 and 25 were included in the Law on Drug and Medical

Devices. In accordance to the Law articles Health Minister Order 183 on registry of

adverse drug reaction (ADR) was approved in 2006 and it was revised and newly

approved as Order No378 in 2010.

A number of important elements of pharmacovigilance is described in those legal and

regulatory papers such as reporting and reviewing of ADR. For instance healthcare

staff and citizens are required to inform the ADR through the website

www.gajnoloo.epharm.mn, while hospitals and pharmaceutical organizations have to

inform and register ADR. Pharmaceutical supplying organizations should have box

and form to fill in to collect ADR information. Hospitals and Pharmaceutical

organization has to submit the ADR registration report in order to extend its

permission certificate of conducting pharmaceutical activities. Medicine therapeutic

committees of tertiary and secondary hospitals will be responsible for both of

registration and assessment, and primary healthcare facilities and private hospitals

are required to register ADR. The Medicine therapeutic committee of hospitals are in

charge of conducting assessment on the information of ADR. Every quarter, those

http://www.gajnoloo.epharm.mn/

22

committees of hospitals required to submit the assessment report to Drug Regulatory

Division, DOH. The reporting guideline along with its form is defined in the Health

Minister Order No378.

However, there are some gaps in the regulatory papers which make the insufficient

legal provision for pharmacovigilance system. For instance, unclear regulation

between pharmaceutical organization and DOH in terms of timeline of reporting,

manufacturer and marketer cooperation has not defined and non existence about the

assignment of special officer for the vigilance purpose. The issues of actions

following the assessment are not clearly specified. The requirements for reporting

safety issues related to specific categories of products including vaccines, biologicals,

and biological products are not described. Adverse drug event is explained in the Law

but other terms including adverse drug reaction and serious drug reaction are not

defined in the legal papers.

Guidelines

Detailed guidelines and requirements on enabling adequate education and

experience level of the focal person, reporting timeline (periodicity and delay) and

means of reporting of safety issues are missing.

Organizational structure

In terms of organization, vigilance activities are organized and performed at DOH.

Focal person designated in charge of pharmacovigilance in 2011.Pharmacology Sub

Committee members are involved in the review of the information transmitted through

the vigilance network.

Internal procedures

External information sources and reference materials for decision making on ADR and

safety monitoring are not readily available and there is language barrier for the

responsible people. External experts are not invited in the assessment process.DOH

does not have any defined pharmacovigilance plan and maintain the procedure to

register and assess day to day ADR reports. The timeline for the assessment and

decision making on ADR is not defined and internal tracking system to follow the

targeted time frame is not working. Up to date, any quality control measures including

peer review on ADR were not conducted and any recommendation on ADR was not

issued from the involved parties. Also manufacturers, importers, exporters and

distributors are not involved in the vigilance activities and they are not inspected.

23


Human resource is not sufficient, supply of relevant equipments is not enough and

education and experience of the focal people need to be improved.

Records and outputs

In 2011, there are 33 information on ADR was reported and 21 of them were

assessed by the Pharmacology Sub Committee. Human Drug Council did not discuss

those information and assessment reports and there is no existing follow up action. It

shows the poor reporting, assessment and output on ADR.

In 2011, 1 case of ADR came from patient. Website www.gajnoloo.epharm.mn does

not work. It shows the lack of citizens and medical professionals involvement. DOH

does not organize basic campaigns on a regular basis to promote adhesion to

vigilance.

Availability of information

The information on ADR in Mongolian is not available to the public and medical

professionals except one article published at the journal “Drug Information” from

DOH.

3.10 Control of Clinical Trials

Legal basis and guidelines

The legal environment on clinical trial was enabled within the following articles of the

health related legal papers. They are article No 21 of the Law on Drug and Medical

Devices, article No26.1 of Law on Health and Health Minister Order No 223 approved

in 2007. In 1999, the Medical Ethics Committee was established in order to oversee

the ethical codes implementation within the medical research conducted in the

country. The Committee has to develop general ethical guideline for the medical

research ethical subcommittees, conduct review and assessment of the clinical trial

request materials, make changes and notification in the initial protocol of clinical trials

and evaluate the completed trial. However, the Committee does not have power to

stop or change the clinical trial if there is ethical conflict occurrence and its action is

limited only within the submission of the report to the related administration authority.

Numbers of important elements of the clinical trial were approved by the Health

Minister Order 223. They are definition of adverse drug reaction, serious adverse

reaction, formats of reporting those reactions, reporting of the adverse reactions

within 10 days and defined criteria, accredited hospitals and laboratories for

conducting the man involved researches, the ethical duty of sponsors in provision of

http://www.gajnoloo.epharm.mn/

24

healthcare services, ethical issues of the medical research sponsored by foreigners

and the duties of researcher and sponsors in getting informed consent.

However, some of the issues are missing in those regulatory papers. For instance,

criteria and requirement of the licensing of manufacturers and importers of

investigational drugs, requiring the products for investigation to comply with the

applicable GMP are not clear and guideline to control the import and export of the trial

drugs are not defined. The criteria for the selecting the principal investigator, his/her

roles and responsibilities and other team members are not well defined. The definition is

limited within the sentence that is “man involved research should be guided by the

highly experienced personnel under the well developed study design”.

The issues of clinical trial and other biomedical research activities are mainly

organised and managed by the Medical Ethics Committee and drug divisions of

MOH and DOH have very much limited participation which is submission of the

information about clinical trials are reported to the Human Drug Council. There is lack

of mechanism to enable good cooperation between the ethical committees and Drug

Divisions of MOH and DOH.

Ethical oversight

Ethical oversight of clinical trials is managed by the Medical Ethics Committee on

Medical Research within the Biomedical Research Ethics Code based on the

Declaration of Helsinki. The main activities of the Committee, its composition with

chair, deputy, secretary and other members, requirement for the members, auditing

process and reviewing of the clinical trial protocol and its amendment approved

without informed consent are defined and regulated by the Health Minister order No

223. Also the issue of conflict of interest was specified in detailed manner including

the main policy on conflict of interest, contract format and declaration formats. It was

not able to evaluate the documentation of above mentioned activities.


About the organizational structure, there are 5 Ethical Sub Committees at Medical

Institute, Health Science University and other research organizations and they follow

the guidelines and rules developed by the Medical Ethics Committee. The Medical

Ethics Committee conducts assessment of the sponsored trials and researches while

studies for postgraduate degrees are reviewed by the Medical Ethics Subcommittee

at Health Science University. There is weak mechanism to exchange information

among these committees and there is no existing joint database of the biomedical

researches.

25

Assessment procedures

Assessment procedures are defined at the same paper Health Minister Order No223.

The Medical Ethics Committee conducts assessment of the research materials,

external experts are invited and its regulation is approved. The similar criteria are

used for the researches except some additional criteria were approved for the

researches sponsored by the foreign organization. The Ethical Committee does not

ask inspectorate to control the quality certificates GMP, GCP and GLP of the

manufacturers, healthcare organizations and laboratories. Drug and Medical Devices

Division, MOH does not control the Committee activities and lack of cooperation.

Information availability

The list of the approved trials and assessment report are not published for the

general public and it was difficult to see what kinds of studies are going where and

conducted by whom. In 2011, the Committee received 6 applications of new

research, 1 amendment application and issued approvals for 4 applications.

The review of the clinical trial section is based on legal and regulatory papers due to

the busy schedule of the Secretary of the Committee.

3.11 Regulatory inspection and enforcement activities

Legal basis

Regulatory inspection and enforcement activities are defined in the Law on State

Inspection and Monitoring and Law on Drug and Medical devices. The Law on State

Inspection and Monitoring defined details of inspection activities with purpose of

relevant law enforcement, including how to define the timeline, assignment of

inspection officer, his/her responsibilities and rights, check compliance with the

applicable regulations and assigning related fines to the organizations. In according

to the article No15.1.5.of the Law on Public Service, it is not permitted to conduct

inspection at the foreign manufacturing premises of the company which applied for

the permission to include its drug into the Drug Registration List. In the other hand,

the capacity of the national personnel should be improved in order to conduct the

inspection at the foreign premises.

Guidelines

Environmentally conscious disposal of expired/unusable substances reagents and

finished products is regulated by the joint order No249/201 of Health Minister and

Nature, Environment and Tourism Minister.

26

There is not any guidance on the compliance and enforcement strategy taken by the

NRA defining the pyramid of sanctions applicable and conducting pre- and post-

licensing inspections.


The organizational structure is complex and several independent organizations are

involved. GASI is responsible for external inspection and monitoring while Drug

Regulatory Division of DOH is in charge of internal monitoring. The Inspection Offices

at aimag and city level and Border Inspection Units are working under the GASI.

Those offices and units use and follow all the guidelines and rules approved by the

central organization. About the internal monitoring, some of the activities of DOH are

transferred to Health Departments at aimag and city level. But still there is need to

improve the information exchange and cooperation.

Quality Management system

In according to the article No 4.1.5 of the Law on Government Inspection and

Monitoring, GASI has been implementing a quality management system ISO 31000:10

which is risk based standard to improve the inspection process. Top management

provided political and financial support for introduction of the system and focal person

was assigned and trained. It has 85 check lists which contains 29 indicators and

criteria and brochure on proper usage of these checklists was published and

distributed to the personnel. The baseline evaluation was conducted and result was

introduced to the staff. Except the above mentioned quality improvement system,

once a year, the monitoring division conducts internal auditing for every division of the

Agency. Report of audit and follow up actions are introduced to the staff and

discussed among them.

Internal planning and procedures

In 2011, GASI developed inspection and monitoring checklist based on the national

standards for manufacturer, importing company and pharmacy and the checklist was

expanded by some of the indicators and criteria of GMP, GDP and GCP. Documented

procedures are implemented for the followings; the planning of inspection activities

showing in particular the duration and frequency of the inspections, internal planning

for inspection activities is established and updated to cover all regulated activities, the

preparation and the development of adequate materials for an inspection, the

inspections and in particular on assessing the critical steps of the processes and

validation and for inspections based on specific requirements for specific classes

of products and facilities (generics, sterilization, innovator products). They have a

standard format for reporting inspection gaps or deficiencies such as an inspection

27

report. The same criteria and indicators are used for national, international, public and

private organizations.


There are 35 inspectors in charge of drug and bio preparation inspection in GASI.

However human and other resources are really lacking. In rural and border offices do

not have complete numbers of inspection officers and education and experience level

of all the officers capacity need to be improved. The training needs should be defined

and follow up actions should be done including different training at national and

international level. The enrolment criteria criteria is limited within the exam for public

servant, education level and number of years having working experience and those are

not enough to select the well prepared personnel as inspection officer. Therefore, these

criteria need to be expanded in direction of more professional side. There is lack of

adequate equipments, office supply and work space especially for the rural and border

offices. The drugs for the inspection activities are collected and placed in the offices

because storage is not available. Transportation and communication service is very

poor, especially border officers are not provided by the transportation to conduct the

inspection.

Records and output.

The database of the inspected organizations is established and all the relevant

materials are stored as soft files including inspection assignment, inspection report,

explanation of the inspection to the inspected organization, final decision etc. The file of

inspection and monitoring activities are collected and stored for every organization and

it is reviewed when the organization apply for further permissions such as extension of

the licenses etc. In 2011, as result of the inspection activities, 11 importing companies

were temporarily closed while 5 other companies were completely closed down. Also 3

issues of organization and company staff were transferred to the relevant judge. There

is need of improving network and programme supply.

Availability of information

Inspection and monitoring information are placed on the website

www.inspection.gov.mn in order to disseminate to the general public. The list of the

designated inspectors is available to the companies subjected to inspection for

one year and summary results (notices of compliance penalties, prosecutions

engaged) of the conducted inspections were published on the website. The whole list

of the inspected organizations was not published and was not available to the public.

http://www.inspection.gov.mn/

28

3.12 Quality Control Laboratory

Legal basis

Currently, there are 3 state laboratories to perform quality control testing of

pharmaceutical products. The first laboratory of testing pharmaceutical products was

established in 1965.In 2002, according to the Parliament Resolution No58 five different

laboratories were joined under the name of United Central Laboratory of the GASI.

Now United Central Laboratory’s Drug and Bio preparation unit is the main laboratory

and conducts quality control testing of the pharmaceutical products in the country. The

other two laboratories, one is at Health Science University and another is drug

reference laboratory of MOH at Public Health Institute, are performing tests within the

limited area for the contracted organizations. Therefore, the assessment was mainly

based on the activities of the United Central Laboratory. It has received an

accreditation and a right to conduct the quality control testing and issue the official

result from the State Standardization and Meteorology Agency. The Laboratory is

regarded as external quality control laboratory and inspection experts are assigned by

the Chair Order of the Laboratory. These three laboratories do not have a mechanism

to share and exchange the information with each other and maintains independent

activities by themselves.

Guidelines

There are number of guidelines in relation to conducting quality control testing for the

pharmaceutical products. In according to the article No 6.2.1 of the Law on Drug and

Medical Devices on safety and quality surveillance for the drugs and biologically active

products is enabled testing at pre and post marketing periods. Collection, packaging

and submission of samples are regulated by the Government Resolution No 39

(2004/04/11) on collection of samples and GASI Chair Order No 35 on sample

storage duration, sample size and sample receiving. The Central Quality Control

Laboratory issued list of the standards and reference materials which should be used

in drug quality control testing. Complaining and appealing against the decisions of the

Laboratory is regulated by the appeal guideline approved by the State Standard and

Meteorology Agency.


Drug and Bio preparation unit of the United Central Control Laboratory has several sub

units including Chemical, Microbiological, Biological, and Traditional medicine

technical sub units. Chemical sub unit conducts test for drugs and bio preparations.

Microbiological sub unit do the Sterility test, Microbiological contamination and

29

Potency of antibiotics. Biological sub unit carries out Progenies test, Toxicity test and

LAL test. Traditional medicine sub unit tests Macro- and micro-scope examination,

photochemical test and Microbiological test. The Unit does not have a full capacity of

conducting relevant tests for different vaccines.

Quality management system

The United Central Control Laboratory has been implementing ISO/IEC/17025:2007

standard based quality management system. The guideline for the quality system

management and implementation was published and distributed to the staff and quality

manager was trained. 13 objectives are defined and have been implemented in order to

completely implement the quality system. The monitoring reports are presented and

discussed among the staff and managers. Also annual internal auditing has been done

continuously and follow up actions are defined and implemented.

However, the quality guideline of the laboratory is very general and serves all the units

of the laboratory. There is only one quality manager is working for the whole laboratory.

Every unit does not have the sub guideline included its own special issues and Drug

and Bio preparation unit does not have independent quality manager. The Chair of the

unit is in charge of the quality management system.

The United Central Control Laboratory attended the programme on Evaluation Scheme

of Nutrition Products Testing by FEFAS and other programme organized by APLAC.

Within framework of these programmes, the capacity of the United Central Laboratory

was evaluated (excluding drug and biological products testing). The drug and

biologically active products testing unit was not attended these kinds of compared

testing international programmes due to its lack of adequate equipments and well

trained experts. The United Central Laboratory follows all the quality control guidelines

and rules but still there is need of updating and revising them in accordance to the

international standards. The lab does not have a lab equipment calibration and

validation program as part of the quality systems.

Quality control procedures

Although there are several documented procedures implemented for preparation and

storage of standards, samples, performing the testing, and dealing with non complaint

products, it has not reach to the standards properly in reality. The inadequate space of

storage room of this laboratory does not keep the retention samples. Laboratory

administration applies the strategies, programs and procedures for introduction and

validation of new or improved testing. The experts used to record the test performance

and reporting result on their own notebook. Now standard formatting worksheet has

30

been implemented in those procedures. Also Drug and Bio preparation unit

implemented the documentation procedures for meeting with clients when open day to

the public as a report only. There is no other channel of reporting and distribution of

information.


Currently United Central Laboratory’s Drug and Bio preparation unit has 15 experts

which are not sufficient. The workload has been increasing and number of tests for

drug sample has been growing because of establishment of Drug Division of DOH and

its active requirement of sample testing. Also the numbers of experienced experts are

few and it takes 3-6 months to train the newly recruited expert internally. The

Laboratory chair defines by his order the experts and their task assignments and it may

influence the transparency of the organization. There are not any mechanisms to

manage any conflicts of interests and confidentiality mechanism just started to

implement. Therefore, human resource capacity needs to be improved not only for the

analysts but also for the technical personnel.

Infrastructure and equipment

Work space and storage are not sufficient and supply of transportation and

communication is not enough. There are not adequate equipment and instruments for

testing activities. Procedure for cleaning, calibration and maintenance activities of the

equipments are not very good and not in timely manner. The most of the equipments

manufacturer instruction is missing and not translated into Mongolian. Therefore

documentation procedures are not implemented for the correct use of the equipment

according to the manufacturer instruction. The log book of the equipment is fulfilled by

wrong way so it does not capture the right information. The laboratory has a new

HPLC that is not being used for 2 years and just have been inviting external expert

from abroad. Clearly, there is need to update the current equipments, improve the

equipment proper usage, strengthen equipments maintenance and training of the

engineers on appropriate maintenance of the equipments.

Reference and standards/ materials and reagents

The first national pharmacopeia was published and it supports quality control testing

activities in some extent. There is need to improve the tendering process to supply the

reference materials and maintain regular supply system for reference

standards/materials. There is need to strengthen documented procedures are

implemented for sourcing, preparation storage and use of reagents of assured quality.

31

Safety programme

The list of hazardous substances is approved by the Government and it has not

updated recently. The responsible staff is not designated for the management of a

safety programme and it may interrupt the continuity of the safety programme.

Sub contracting, records and outputs

The United Central Laboratory does not transfer some of its responsibilities and make

subcontracts with other laboratories. Although the data base of all the products tested

is maintained, it needs to be improved and modern equipments to write and issue

laboratory papers. Analysts write all the information and reports by hand on the paper

and then they insert them to the software programme by hand. Therefore, they need to

have updated equipments and software programme to eliminate the double writings.

The United Central Laboratory issues certificates of analysis under its own name.

3.13 Control of Narcotics, Psychotropic Substances and Precursors

Legal Basis

Mongolia is signatory member of the International conventions on Narcotic Drugs

(in1990), Psychotropic Substances and Drugs (in 1999) and Narcotics Psychotropic

Substance Control (in 2001) which are approved by UN in 1961, 1971 and 1981

respectively. In Mongolia, Law on Narcotics Psychotropic Substance Control was

approved in 2002 and was amended in 2011. The purpose of the amendment was to

improve the control and regulation of narcotic drugs including definition of special

prescription for those drugs, requirements for importing organizations and

pharmacies in handling narcotic drugs and changes in assignment of fines according

to the social changes. Also the National Committee with its own budget and office

was established in order to strengthen control of illegal usage of narcotic and

psychotropic drugs. The responsibility of the Committee is to prevent from the crime

related with those drugs, reduce illegal usage and supply of those drugs and

substances, improve the legal environment and develop international cooperation in

this area. Moreover, in 2011, the guideline for pain management using those drugs

was published with support from MCA.

However, there are gaps in terms of cooperation, human resource and multiple

parties’ involvement. There is poor cooperation and information exchange between

the organizations working to control the circulation of those drugs and substances

and joint information database is absent. The surveillance study was not conducted to

see the appropriate use of narcotic drugs and psychotropic substances. There is non-

existence of legal provision to assign focal person at every organization handling with

32

the drugs and substances. It could be exemplified by the recent case of narcotic

drugs were sold by hospital nurses. Civil society and healthcare staff involvement in

control of those drugs and substances is very poor due to lack of relevant information

and references and insufficient promotion actions to raise the awareness. Moreover

there is need of building capacity in terms of human resource, funding and logistics.

Lack of personnel who have the adequate knowledge and experience in the field is

described by few of the officers who almost have not attended the relevant trainings

at national and international level.

3.14 International Cooperation and Harmonization

Parliament Resolution No 68 on Approval of Drug Policy in 2002 promotes the

international cooperation and harmonization of the pharmaceutical sector in its article

5.2. However, there is no policy paper which defined the main principles and direction

of international cooperation in accordance to the Parliament Resolution.

MOH has signed on the cooperation agreement with the central drug regulatory

organization of Germany, Poland, Turkey and Korea. The cooperation agreements

aimed to improve drug safety, licensing and assuring through information sharing and

capacity building. In July 2011, Drug Division of DOH signed cooperation agreement

with KFDA of Korea in order to intensify the implementation of the Drug Policy. The

cooperation proposal on drug safety issues were delivered to the relevant

organization of China. However, there is no existing official cooperation with Russian

Drug Regulation Organization at central level and drugs imported from Russia

compose the most of the drugs in the market.

MOH recognizes and uses regulatory decisions, reports inspection, evaluation,

(vigilance), guidance, certification schemes and formats recommended by WHO. For

instance, in according to WHO guideline, the requirements of GMP, CCP, BCPP

certificates were included in the regulatory documents. Up to date, the certification

schemes are not provided in the country and the preparation work is in the process.

Health and Education Division and United Central Laboratory do not participate in

peer reviewed or joint activities due to their affiliation under the GASI. Also they have

very poor participation in proficiency testing schemes, regional collaborative studies

or the WHO External Quality Assurance Assessment Scheme due to insufficient

capacity of the laboratory, lack of adequate human resource and other logistic factors.

33

4. Conclusions and Recommendations

Conclusions

The Review of Drug Regulatory System of Mongolia was completed and the

followings are concluded:

The legal basis of Drug Regulatory is established and the government

supports and undertakes definite actions towards the implementation of the

National Drug Policy and its strategies,

Some regulatory activities, such registration, and import authorization is

relatively stabled.

Establishment of the online system “Licemed” for drug registration, licensing

and special permissions

Funding and support from donor organizations are increased in recent years.

Some WHO standards and guidelines are used in Drug regulatory activity

Establishment of NMRA is emerged

Mongolian first Pharmacopeia is published

However, the following deficiencies occur in the Drug regulatory systems:

NMRA has little power and autonomy, and oversaw a limited range of

regulatory functions with little accountability or managerial commitment.

Most of the regulatory organizations suffer from staff shortages. There is lack

of training and specialization in national and international level.

Assessors and inspectors were not at the level of current scientific and

technical expertise needed for their regulatory tasks.

Regulatory requirements and processes were not in line with recommended

WHO standards. Guidelines, SOP, reference, information and statistics are

inadequate.

Medicines regulation was not carried out to the full extent required to ensure

the quality, efficacy and safety of medicines in Mongolia. Pharmacovigilance

and post marketing surveillance is not performed.

Quality Management System is not established in DOH. Documented

procedure is not implemented in Drug regulatory system

34

Drug regulatory functions are undertaken by different organizations which

make coordination difficult and create inefficiencies.

Impartiality, transparency and accountability are insufficient. There are no

internal policy on potential conflicts of interest for staff members and no model

format for a declaration of conflicts of interest for staff. There is no documented

Code of conduct for staff members involved in drug regulatory and experts.

Information management systems and Communication activities of Regulatory

system are insufficient.

International Cooperation and Harmonization are weak

Licensing of drug manufacturers and importers, distributors is performed and

issued by Medical Care Division, DOH

35

RECOMMENDATIONS

Improve law implementation, and develop policy, plan and regulation needed

for regulatory activity

Provide the power and autonomy of Regulatory Authority and increase

funding, human and other resources. Strength Drug Regulatory Functions.

Establish Medicine Regulatory Agency, and organize and perform drug regulatory

activities at central level.

Licensing of drug manufacturers and importers, distributors should be

performed and issued by Drug Regulatory Division, DOH.

Improve information management systems and Communication activities of

Regulatory system. Establish the mechanism of information and practice

exchange and implement.

Establish Quality Management System in DOH and implement WHO

guidelines and ISO standards.

Ensure that the local drug organizations comply with WHO GXP guidelines.

Improve the quality, efficacy and safety of medicines. Establish a post

marketing surveillance and pharmacovigilance activities.

Improve impartiality, transparency and accountability of Drug Regulatory

organizations and stakeholders.

Develop a policy paper to expand the international relationship. Enrol as a

member of the international organizations working in the drug and biologically

active products.

Develop guidelines, SOP, references needed for drug regulatory activity.

Implement a documented procedure in Drug regulatory system.

Strength human resource development, provide the training and specialization

of regulatory staff in national and international level.

Improve the Information management system and Communication activities

of Regulatory system.

Prepare assessors and inspectors with current scientific and technical

expertise needed for their regulatory tasks.

36

Annex 1 Assessment tool MODULE 1 GENERAL INFORMATION: 1.1 Information on the country

Country: Mongolia

Name and address(es) of Institution(s) assessed: MOH, HSUM, NGO-Em association

Assessment focal point: Ulaanbaatar

Address of focal point: Ch.Munkhldelger, Head of Pharmaceutical and Medical Devices Division, MOH

Tel of focal point: Government building VIII Olympic street Sukhbaatar district 14210

Fax of focal point:

Email of focal point: [email protected]

1.2 Information on the assessment

Date of the assessment: 2011.11.16-12.20

Purpose of the assessment: To give an overview of the legal basis, structures, processes and implementation of medicines regulation in Mongolia

Scope of the assessment: To cover all organizations involved in drug regulatory

Assessment performed by: Purevsuren S

Munkhdelger B

Address of assessors: School of Pharmacy Health Sciences University of Mongolia Ulaanbaatar, Mongolia-14210 PO-48, Box-186

Tel of assessors: 976-88007805, 976-99090732

Fax of assessors: 976-11310293

Email of assessors: [email protected] [email protected]

MODULE 2 NATIONAL REGULATORY SYSTEM COMMENTS: 2.1 Structure 2.1.1 The Ministry of Health has delegated or assigned to one or more

authorities (institutions/agencies/autonomous bodies) its responsibilities regarding the regulation of pharmaceutical products.

+

2.1.2

The responsibilities/functions/organization of each of these authorities is clearly defined, in particular as regards the scope of the regulation (regulatory functions) they have under their control.

+ Health Minister’s Order N278, 2011

2.1.3 All the regulatory areas (regulatory functions) are under the supervision of at least one of these authorities in charge of it.

+

2.1.4 The activities of the various authorities involved are coordinated by an administrative mechanism.

+ By Law on Drug and Medical Devices , State Inspection Law

2.2 Legal basis for the establishment of the regulatory system 2.2.1 The legal basis of the regulatory system applied to the

pharmaceutical sector is clear and comprehensive. +

2.2.2 The main steps to be followed for the implementation of the + NRA established

mailto:[email protected]

mailto:[email protected]

37

legislation are defined and followed. 2.2.3 The legislation enables the appropriate institutions to issue

regulations. +

2.2.4 The development of regulations involves the Regulatory Authorities in charge of their implementation and enforcement.

+ Registration regulation

Assurance regulation

Regulation on registration and report of side effects

Regulation of Pharmacopeia Council

2.2.5 The development of regulations involves the various sectors of the civil society (such as NGOs, consumers and patients, representatives of health professionals and industry,).

+ Em association

2.2.6 Adequate regulations have been enacted and published. + 2.2.7 The legislation is made known to the people who are to be governed

by it and the ways of communication used are adequate. +

MODULE 3 NATIONAL REGULATORY AUTHORITY (NRA) COMMENTS: 3.1 Legal basis 3.1.1 The legislation provides for the establishment of a NRA and clearly

defines, its mission, Terms of Reference, powers, functions and responsibilities.

+ Law on Drug and Medical Devices , State Inspection Law, Government Service Law, Government Agency Law, Health Minister’s Orders

3.1.2 If more than one institution is involved, legislation provides for coordination/linkage among these institutions and the respective empowerment is defined.

+

3.1.3 The legal provisions specify that the NRA has the power to/or the delegation to decide whether a specific product falls within the definition of a medicinal product, a medical device, or any another category of products.

-

3.1.4 The legal provisions specify that the NRA has the power to/or the delegation for appointing special officers/inspectors and provides them with adequate powers to carry out inspection of pharmaceutical products and practices.

- Internal inspection

3.1.5 The legal provisions specify that the NRA has the delegation, the enforcement powers and responsibilities to deal with non-compliant products.

-

3.1.6 The legal provisions specify that the NRA has the power to/or the delegation to issue a written notice of violations to companies and recommend their prosecution.

+

3.1.7 The legal provisions enable the NRA to issue and publish appropriate guidance or notes for applicants.

+

3.1.8 The legal provisions enable the NRA to set up technical/scientific advisory committees for regulatory purposes.

± No scientific advisory committees

38

There are Technical committees Licensing Committee, Assurance committee

3.1.9 The legal provisions define the terms of reference for each advisory committee in particular their role in the decision making process, and circumstances under which the advice of the experts/advisory committees must be obtained by the NRA.

-

3.1.10 The legal provisions enable the NRA to collect fees for regulatory service provided

+ Registration and assurance fee

3.2 Corporate Governance 3.2.1 There is a governing /administrative body for strategic development. + Human drug

Council 3.2.2 The functions of the Governing Board/Council are defined,

documented and implemented particularly in advising on strategy and orientation of the NRA.

+

3.2.3 There are bodies within the DRA to manage and organize routine functions.

+

3.2.4 The roles and responsibilities of such bodies are defined and documented particularly for implementation of routine decisions, strategic objectives and reporting thereof

+

3.2.5 Communication channels among such bodies are established. + 3.2.6 There is a scientific body to advise the NRA on scientific matters and

future orientations. -

3.3 Institutional Development 3.3.1 The NRA has established an Institutional Development Plan which is

implemented and updated. -

3.3.2 The Vision and the Mission Statement for the NRA is established. - 3.3.3 The objectives of the NRA have been set in particular target time

frames for the various functions. -

3.3.4 Action plans are established and implemented to achieve the objectives set.

-

3.3.5 Indicators are established to monitor/assess progress towards the objectives.

-

3.4 Organization and structure 3.4.1 Regulatory activities are organized and performed at a central level

of the country +

3.4.2 Decentralized activities to other agencies/authorities follow the standards, guidelines and procedures as agreed/decided with the central authority.

+

3.4.3 In case of decentralization, a mechanism of exchange of information is established and implemented in order for the decentralized organization to receive requests and/or directives from the central authority and to report to it.

-

3.4.4 The mechanisms in place allow exchange and harmonization of best practices, appropriate cooperation and collaboration among the decentralized organizations.

-

3.5 Quality Management System 3.5.1 The NRA has implemented a Quality Management System for all the

regulatory processes. -

39

3.5.2 The NRA’s top management is committed to the development and implementation of the Quality Management System in particular by providing financial and organizational support.

+

3.5.3 The Quality Management System is based on recognized standards as reference (e.g. WHO, PIC/S, ISO, other).

-

3.5.4 A quality policy and related quality objectives are defined and documented.

-

3.5.5 A qualified person is designated as responsible for the development and implementation of the Quality Management System.

-

3.5.6 The NRA has identified its processes for each regulatory function, determined their interactions and methods needed to control these processes.

± Registration regulation, Assurance regulation, Health Minister’s Orders, Order of Chairman of Department of Health

3.5.7 The documentation needed to establish, implement and maintain the QMS is defined (Quality manual, records, SOPs, etc).

-

3.5.8 The documentation required by the QMS is controlled following a documented procedure.

-

3.5.9 A documented procedure is established by the NRA to plan, and to assess if the QMS is effectively implemented and conforms to planned arrangements.

-

3.5.10 Internal audits of the complete QMS are done at least once every 12 months. Records of the results are maintained.

-

3.5.11 The corrective and preventive actions taken as a result of audits or from other non conformities are implemented and documented. Their efficacy is checked and documented.

-

3.5.12 The top management of the NRA reviews on a regular basis, at least once every 12 months, the QMS to evaluate its efficiency as well as its effectiveness. Records of the review are maintained.

-

3.6 Funding 3.6.1 The sources of funding of the NRA to perform its regulatory

functions are defined. + Salary from

Ministry of Finance

3.6.2 The scale of fees for regulatory services provided are established and published, including any preferences applied to local products or industry.

+ Registration fee, assurance fee

3.6.3 Provisions concerning fee reductions or exemptions to ensure the availability of vital or life-saving drugs for a limited market are provided.

+ Tuberculosis medicines HIV/AIDS medicines, diabetic medicines, cancer medicines are free of charge

3.6.4 Funding is partly provided by development partners or donors such as WHO, The World Bank, etc.

+ ADB

3.6.5 The NRA has the authority and the procedures in place to collect fees and internally utilize the generated funds.

+ Not use the fee internally. Fees for regulatory activities are paid to state budget

3.6.6 The NRA is obliged to periodically publicize its budget. -

40

3.7 Management of human resource 3.7.1 An organization Chart/organogram for the NRA staff is established

and updated. +

3.7.2 The NRA’s key technical and scientific personnel have been identified based on their authorities and responsibilities.

± Vice Chairmen for Medicine, Head of Department of Drug Regulation, No scientific key person

3.7.3 The duties, functions and responsibilities of the key personnel are established in the respective job descriptions.

+

3.7.4 The NRA has established the necessary competencies (education, training, skill and experience) for the key personnel to perform the assigned work.

+

3.7.5 The NRA is able to select and recruit its own staff following documented procedures based on its own written criteria (experience, minimum educational background, advanced training, etc.).

+ Government Service Counsel is responsible for selection of state staff

3.7.6 An initial and periodic staff appraisal system is established to review performance and competencies, identify academic and training needs; and agree on performance targets.

-

3.7.7 There is an induction program for newly recruited staff. - 3.7.8 A training plan is established for all staff in order to satisfy/fulfil the

needs identified. Training activities are performed and recorded by the NRA.

-

3.7.9 A documented mechanism is in place to evaluate the impact and to demonstrate the effectiveness of the training activities.

-

3.7.10 Budgetary provisions are made for staff training. +

3.8 Committees and external expertise 3.8.1 The NRA takes advantage of external experts and involves them in

its regulatory processes. +

3.8.2 A model contract between the NRA and each external expert defining roles and responsibilities is established and signed by both parties.

+

3.8.3 The NRA has set up advisory committees of experts involved in the regulatory processes of the NRA.

-

3.8.4 There is a written policy/procedure for the recruitment and the designation of external experts and members of experts committees calling for candidates, defining the review by a selective jury/panel, appointments and publishing of the final decision but also to cross off.


3.8.5 Documented procedures are implemented for the management of the advisory committees (designation of chair and composition, secretariat responsibilities, quorum, declaration of interests, agenda, minutes and operational procedures).

± Annex 5 of Health Minister’s Order 402, 2011 Declaration of interest for members Human Drug Council and Sub Committees

3.8.6 There is a general policy on potential conflicts of interest for external experts and members of advisory committees.

±

3.8.7 There is a general policy on confidentiality and a code of conduct for -

41

external experts and members of advisory committees. 3.8.8 The NRA is involved in a global network with relevant scientific

associations and professional societies. -

3.8.9 There is a documented mechanism to manage potential conflicts of interest of internal and external experts and members of committee by collecting declarations of interests, including ensuring updates of these declarations, for all regulatory functions.

-

3.8.10 The agenda of the technical/advisory committee is elaborated prior to the meeting and the minutes of the discussions are recorded.

-

3.9 Transparency and confidentiality 3.9.1 The legislation stipulates the requirements on confidentiality and

transparency. + State Employment

Law 3.9.2 There is a documented policy on public disclosure of information

with exemptions/exceptions. + State Employment

Law 3.9.3

Information on legislation, regulations, procedures and guidelines are publicly available and are kept up to date on websites or other mechanisms used to ensure the proper availability of information.

+ www.moh.gov.mn, www.doh.gov.mn, Journal of Drug information

3.9.4 An annual report with the allocated budget mentioning the origin of funds, is published on a periodic basis and is publicly available.

-

3.9.5 The decision-making processes as well as decision criteria are publicly available.

+ www.moh.gov.mn www.doh.gov.mn, Journal of Drug information

3.9.6 The information on decisions is publicly available, including the negative decisions in specific cases (i.e. when legislation permits) in a timely manner.


3.9.7 The Information on outputs of regulatory functions performed is publicly available and kept up to date (web sites or other mechanisms).


3.9.8 The information on sanctions, recalls and public health warnings are published and are publicly available.

+ By media

3.9.9 A guideline on complaints and appeals against regulatory decisions is available.

-

3.9.10 An appeal mechanism against the NRA’s decisions is available and implemented.

-

3.9.11 The NRA consults or involves specific sectors of the civil society (such as NGOs representing health professionals, the industry, consumers and patients) during the development of guidelines.

+

3.9.12 A documented procedure is implemented to consult, collect and to deal with the comments received during the development of guidances.

+

3.9.13 The declarations on interests of internal and external experts as well as members of technical/advisory committee are publicly available.

-

3.9.14 The industry, consumers and patients’ representatives are involved as observers in technical/advisory committee meetings.

+

3.9.15 The agendas of the technical/advisory committees are published in advance and the minutes of the meetings are publicly available.

-

3.9.16 A competent contact person or a public relations unit is established and known by the interested parties.

-

3.9.17 The NRA regularly organizes meetings with the key stakeholders Meeting with the

http://www.moh.gov.mn/








42

and open days for the public. key stakeholders is not regularly Open days for the public

3.9.18 The NRA is represented at meetings organized by the stakeholders (industry associations, professional associations of practitioner, patients associations,…).

+

3.10 Independence and impartiality 3.10.1 There is a documented Code of conduct /activities/ for staff

members involved in drug regulatory functions. -

3.10.2 There is an internal policy on potential conflicts of interest for staff members/personnel.

-

3.10.4 There is a documented policy/procedure to avoid the accumulation of responsibilities for registration, procurement or reimbursement agreements with the same authority/individuals.

-

3.10.3 There is a model format for a declaration of conflicts of interest. -

3.11 Infrastructure 3.11.1 The work space and work environment are adequate. - 3.11.2 The equipments provided for performing the regulatory functions are

adequate. -

3.11.3 Support services provided (for example in terms of transport and communication) are adequate.

-

3.12 Monitoring and accountability 3.12.1 The legislation provides requirements for monitoring and

accountability of the NRA by stakeholders. -

3.12.2 The regulatory processes are regularly and systematically reviewed in order to identify problems, gaps and inconsistency within the regulatory authority.

-

3.12.3 Periodic reports on regulatory processes performed are submitted to the institution/organization in charge of the overseeing and reviewing of the NRA functions

-

3.13 Information management systems 3.13.1 The NRA uses computerized systems for automation of repetitive

functions and for reporting activities. -

3.13.2 The NRA uses computerized systems for data management and for enhancing data import/export capacity.

-

3.13.3 The NRA uses computerized systems for accessing technical/scientific information.

-

3.13.4 The NRA has established an integrated network of all computers related to regulatory functions.

-

3.13.5 The NRA has its own website or has made an arrangement to use others.

+ www.doh.gov.mn

3.13.6 The NRA employs its own IT staff or has assured access to IT services.

-

3.13.7 Documented procedures are in place to gather data and use the software applications as well as query tools.

-

3.14 Communication activities 3.14.1 The NRA has established a communications strategy to maintain

confidence in the regulations and to provide timely, necessary and helpful information.

-

3.14.2 This strategy considers the different target audience (patient, public, industry, healthcare professionals) and the available means of

-


43

communication (media, website, stakeholders meeting, conference) 3.14.3 The NRA has prepared a crisis plan for coping with major incidents

and information that could potentially alarm the public. -

3.14.4 Success of this communications strategy is measured by adequate means.

-

MODULE 4 MARKETING AUTHORIZATION (MA) COMMENTS:

4.1 Legal basis 4.1.1 The legal provision requires one to hold a Marketing Authorization

(MA) before putting a pharmaceutical product on the market. + 7.22 provision of

Law on Drug and medical Devices

4.1.2 The legislation enables the NRA to issue a marketing authorization for a pharmaceutical product, to suspend it for a period of time and to withdraw it.

+ Health Minister’s order N38, 2007

4.1.3 There are legal provisions requiring the applicants to demonstrate the quality, safety and efficacy of the pharmaceutical product that is subject of the application.

+ Health Minister’s order N38, 2007

4.1.4 There are legal provisions regarding the information to be provided with the products (packaging, labelling, leaflet, Summary of characteristics, etc…).

+ 18 provision of Law on Drug and Medical Devices

4.1.5 There is a legal requirement regarding the limited duration of the validity of the MA and for handling periodic reviews to MAs.

Registration for 5 years. No legal requirement for handling periodic reviews to MAs

4.1.6 The legal provisions require the notification to the NRA of any variations to the initial MA which may affect the quality, safety and efficacy of the products. Specific kinds of variations can be subject to authorization by the NRA.

-

4.1.7 The legal provisions envisage the case of demonstrated bioequivalence of multisource/generic products with innovator.


4.1.8 The legal provisions envisage the case of provisional or conditional MA exempting applicants from meeting specific requirements based on the established criteria (orphan drug, public health interest, presumed positive benefit/risk balance).

+ 22.7 provision of Law on Drug and Medical Devices

4.1.9 There is an exemption for pharmaceutical product donations following the established criteria.

+ 22.7 provision of Law on Drug and Medical Devices

4.1.10 The legal provisions specify the MA holder/manufacturer’s liability for defective products.

-

4.2 Guidelines 4.2.1 There are guidelines on the applicable requirements on quality,

safety and efficacy. - No guideline.

Applicable requirements on www.doh.gov.mn

4.2.2 There are guidelines on the content of Product Information Leaflets, Summary of Product Characteristics (SPC), packaging and labelling.

-

4.2.3 There are guidelines on the applicable requirements on various process validations (manufacturing, IT, etc…).

-

4.2.4 There are guidelines on the applicable requirements on analytical method validation.

-

4.2.5 There are guidelines on the applicable requirements on stability -


44

testing of pharmaceutical products (API, finished products). 4.2.6 There are guidelines on the applicable requirements to the

demonstrate bioequivalence/bioavailability. -

4.2.7 There are guidelines for applicants or their representatives on the content of the application, the format and the procedures to follow in order to submit an application for a MA.

- No guideline Application format is on www.doh.gov.mn

4.2.8 There are guidelines for marketing authorization holders defining the types and scopes of variations, the format and the documentation required as well as specifications of the variations that are subjected to prior approval.

-

4.2.9 There is a guideline on drug donation. + Health Minister’s Order 105/2011

4.2.10 There is guidance on risk management programs, pre-marketing risk assessment and development of pharmacovigilance plans

-

4.3 Organization and structure

4.3.1 Marketing authorization activities are organized and performed at a central level of the country.

+

4.4 Assessment procedures 4.4.1 A documented procedure is implemented on a voluntary basis to

allow applicants to meet with the DRA before the submission of an application.

-

4.4.2 Documented procedures/tools are implemented for the assessment of the different parts of the application and for the assessment of specific requirements of specific classes of products (e.g. multisource/generics, products containing new active substances, new strengths, high-tech or particularly innovative products etc.).

-

4.4.3 A documented procedure is implemented to exchange information between the applicant and the DRA if needed.

-

4.4.4 Documented procedures are implemented to periodically review the MAs granted.

-

4.4.5 Documented procedures are implemented for assessing the applications for variation of MAs.

-

4.4.6 There is a model format for the assessment/evaluation report. + 4.4.7 The same criteria are used for the evaluation of MA applications

regardless of the source (e.g. domestic, foreign, public/private sector) of the products concerned.

- Deferent criteria for imported, local, traditional medicines and raw materials. Special regulation for biologically active products

4.4.8 The product information, Summary of Product Characteristics (SPC), packaging and labelling is approved by the NRA as part of the MA.

+ LICEMED

4.4.9

The risk management program and pharmacovigilance plan are approved by the NRA as part of the MA

-

4.4.10 A documented procedure is implemented to follow the commitments of the MAH and in particular the Risk Management Program (see also Module 11 on pharmacovigilance)

-

4.4.11 External information (information sources and reference materials) for decision making on the applications submitted are readily available.

-


45

4.4.12 Documented procedures are implemented to control the quality of the assessment process in place such as peer-review.

± Expert conclusion, result of laboratory analysis

4.4.13 External experts are involved in the assessment of the applications for MAs.

+ Pharmaceutical and clinical experts

4.4.14 An advisory committee of experts is involved in the review of MAs applications.

-

4.4.15 A documented procedure is implemented for decision-making. + Protocol 4.4.16 The decision making procedure takes into account a cost/benefit

analysis. -

4.4.17

A documented procedure is implemented to issue the marketing authorization in a standardized format.

+

4.4.18

The NRA recognizes and/or uses regulatory decisions, reports or information from other NRAs or international bodies for decision making.

+

4.4.19

The procedure takes into account the integration of the different parts of the dossier into an overall benefit/risk analysis assessment.

-

4.4.20 Documented procedures are implemented to ensure the involvement and communication between the assessors and the QC laboratory for product compliance and the regulatory inspectorate for compliance to applicable good practices.

+

4.4.21 There are time limit(s) for the assessment of the applications. + Within 3 months 4.4.22 An internal tracking system is established to follow the targeted time

frames (statutory or not). -

4.4.23 There is a documented fast-track mechanism for specific products of particular public health interest.

- Registration timeframe of products registered in EU, USA and Australia is short. But there is no Fast-track mechanisms

4.4.24 The steps/requirements for waived MA assessment are documented.

-

4.4.25 There is a model format for the decision on a marketing authorization application (approval, rejection, withdrawal).

-

4.4.26 A written marketing authorization, signed by a person with the adequate delegation, is sent to the applicant, accompanied by the approved product information, including conditions or restrictions of this approval.

-

4.4.27 Each pharmaceutical product receives a unique identification number that appears on the labelling/packaging and product information.

+ 18 provision of Law on Drug and Medical Devices

4.5 Human and other resources

4.5.1 The job descriptions for the following staff are defined: head of registration (supervisor), head of registration unit by products and assessors with their areas of assessment (bioequivalence, chemist, medical officer, microbiologist, statistics, Toxicology, PD/PK, etc…).

There should be 4 staffs for registration, but only 2 staffs work at Department of Medicine regulation, DOH

4.5.2 There are enough personnel (internal and external) with the adequate expertise (education, experience and training) for the assessment of the different parts of the application for all types of

+

46

authorized pharmaceutical products.

4.5.3 There is internal planning of human resource utilisation for performing any upcoming and periodical reviews of the applications.

-

4.5.4 The manufacturer's or licence holder's representatives are never involved in assessment work at any level/stage, including expert committees.

- The manufacturer's or license holder's representatives are involved

4.5.5 There are lines of authority reflecting the independence of decision-making in the MAs system from manufacturers, supply systems or government.

+

4.5.6 There is an adequate office, working environment and storage space for MAs files.

-

4.5.7 There is an adequate equipment for MAs functions. -

4.6 Records and outputs

4.6.1 There is an up-to-date list/data base of all the product applications received, approved, suspended or withdrawn and of the applications refused.

Only approved

4.6.2 The NRA retains a master file of each product licensed or applications refused as well as of all the variations and renewals with the supporting documentation including the application, approved drug information, assessment report, risk/benefit assessment, etc. All exemptions are documented in this file.

Only licensed product

4.7 Availability of information

4.7.1 A list of all the approved products is established, updated, published and made publicly available.

+ LICEMED, published every year

4.7.2 A summary of the assessment report as a basis for decision-making is published and is publicly available (positive or negative decision).

+ LICEMED, www.doh.gov.mn Journal Drug information

4.7.3 The list/database of all the licenses withdrawn, suspended or refused is published and is publicly available.

-

MODULE 5 LICENSING OF MANUFACTURERS COMMENTS:

5.1 Legal basis

5.1.1 The legislation requires a company which manufactures or intends to manufacture a pharmaceutical product or an active pharmaceutical ingredient to hold a licence.

+ Licensing Law, Law on Health

5.1.2 The legislation enables the NRA to issue a licence for a manufacturer of pharmaceutical products or active pharmaceutical ingredient, to suspend it for a period of time and to withdraw it.


5.1.3 The legal provisions require the manufacturers to comply with the applicable good manufacturing practices. Compliance with applicable GMP is a condition for keeping its license.

+ Law on Drug and Medical Devices , MNS “Basic requirement of Drug manufacturers”

5.1.4 The legal provisions require notification of the NRA of significant changes/variations to the initial licensing conditions.

+

5.1.5 There are specific legal provisions concerning repacking/relabeling of pharmaceutical products and quality control activities performed by manufacturers.

-

5.1.6 There are legal provisions requiring at least one qualified responsible person for each manufacturing premises.

+ MNS “Basic requirement of Drug


47

manufacturers”

5.1.7 There are legal exemptions to licensing requirements with defined criteria.

-

5.2 Guidelines

5.2.1 A guidance provides detailed information on compliance with GMP requirements. This guidance is mainly based on the WHO model and its supplementary guidance.

+

5.2.2

There are guidelines for manufacturers on the content of the application, the format and the procedure to follow in order to submit an application for a manufacturing license.

-

5.2.3 There are guidelines for waiving license requirements/procedures/steps.

-

5.2.4 There are guidelines for applicants on the definition of types and scopes of variations and the documentation required.

-

5.2.5 There are guidelines on the content of the Site Master File. -

5.2.6 There are guidelines on the appointment and qualification of the Qualified Responsible Person.

-


5.3.1 Licensing activities are organized and performed at a central level of the country.

+

5.3.2 Decentralized activities to other agencies/authorities follow the standards, guideline and procedures as agreed/decided with the central authority.

+


± Mechanism of exchange of information is not so good


-

5.4 Licensing assessment procedures 5.4.1 Documented procedures are implemented for meetings with

applicants before an application is officially lodged. -

5.4.2 Documented procedures/ checklists are implemented to assess the applications for licensing.

-

5.4.3 A documented procedure is implemented for waiving certain requirements or steps.

-

5.4.4 A documented procedure is implemented for assessing the applications for variation of licenses.

-

5.4.5 Documented quality control measures are in place such as peer-review.

-

5.4.6 A documented procedure is implemented for decision-making. + 5.4.7 Documented procedure is implemented to issue the licence in a

standardized format. +

5.4.8 The NRA recognizes and/or uses regulatory decisions, reports or information from other NRAs or international bodies for decision-making.

-

5.4.9 Documented procedures are implemented to ensure the involvement and communication between the administrative staff in charge of the assessment of the application for licensing and the regulatory inspectorate for compliance to applicable good practices.

-

5.4.10 The same criteria are used for licensing regardless of the affiliation (e.g. domestic, foreign, public, private sector, NGO) of the

+

48

manufacturer concerned. 5.4.11 There are defined timelines for the assessment of applications. + Within 21 working

days 5.4.12 An internal tracking system is established to follow the targeted time

frames (statutory or not). -

5.4.13 A written license, signed by a person with the adequate delegation, is sent to the applicant, including conditions or restrictions attached to the licence (validity and renewal).

+


5.5.1 There is enough personnel (internal and external) with adequate expertise (education, experience and training) for the assessment of the applications and for issuing of licences.

+ Staff for licensing is not belonged to the department of Drug Regulation

5.5.2 There is adequate office and storage space (documents, ). -

5.5.3 There is adequate equipment for licensing activities. -


5.6.1 There is a list/data base of all licensed manufacturers. +

5.6.2 The NRA retains a site master file of each premise licensed, including the approved changes with the supporting documentation. The file contains at least the following information: company name, key personnel, premises address/map of the facilities and contact details, equipment, list of drugs and dosage forms approved for manufacture. All exemptions are documented in this file.

+


5.7.1 The list/data base of all the licensed manufacturers is published. + www.doh.gov.mn

5.7.2 The list/data base of all the licenses withdrawn, suspended or refused for manufacturers is published and is publicly available.

-

MODULE 6 LICENSING OF IMPORTERS, EXPORTERS, WHOLESALERS AND DISTRIBUTORS

COMMENTS:

6.1 Legal basis

6.1.1 The legislation requires that a company which imports or intends to import any pharmaceutical product or active pharmaceutical ingredient to hold a licence.


6.1.2 The legislation requires that a company which exports or intends to export any pharmaceutical product or active pharmaceutical ingredient to hold a licence.


6.1.3 The legislation requires that a company which acts as a wholesaler or distributor of pharmaceutical products or active pharmaceutical ingredient or intends to do so to hold a licence.


6.1.4 The legislation enables the NRA to issue a licence for an importer, an exporter and a wholesaler/distributor, to suspend it for a period of time and to withdraw it.


6.1.5 The legal provisions require importers, exporters, wholesalers and distributors to comply with the applicable good storage and good distribution practices for licensing.

+ Licensing regulation

6.1.6 The legal provisions require the notification to the NRA of significant changes/variations to the initial license.

-

6.1.7 There is a legal provision for at least one qualified responsible person for each importer, exporter wholesaler or distributor.

+ MNS “Basic requirement of Drug suppliers”


-

6.2 Guidelines


49

6.2.1 There is a guidance that provides detailed information on compliance with Good Distribution Practice requirements. This guidance is in line with the relevant WHO Guidance.

-

6.2.2 There are guidelines for importers, exporters, wholesalers and distributors on the content of the application, the format and the procedure to follow in order to submit an application for licensing.

-

6.2.3 There are guidelines on waiving license requirements/procedures/steps.

-

6.2.4 There are guidelines for applicants that define the types and scopes of variations and the documentation required.

-

6.2.5 There are guidelines for the content of the Site Master File. -

6.2.6 There are guidelines for the appointment and qualification of the Qualified Responsible Person.

-



+

6.3.2 Decentralized activities to other agencies/authorities follow the standards, guidelines and procedures as agreed/decided with the central authority..

-




-

6.4 Licensing assessment procedures 6.4.1 Documented procedures for meetings with applicants and other

interested parties. -

6.4.2

A documented procedure/standard checklist to assess the applications for licensing of importers, exporters, wholesalers and distributors.

+

6.4.3 A documented procedure is implemented to issue the licence in a standardized format.

+

6.4.4 A documented procedure is implemented for waiving certain requirements or steps.

+

6.4.5 A documented procedure is implemented for assessing the applications for variation of licenses.

+

6.4.6 Documented quality control measures are in place such as peer-review

-

6.4.7 Documented procedures are implemented for decision-making and for the issuance of the licence.

+

6.4.8

Documented procedures are implemented to ensure the involvement and communication between the administrative staff and the regulatory inspectorate for compliance with applicable good practices.

-

6.4.9 The same criteria are used for licensing regardless of the affiliation (e.g. domestic, NGO, foreign, public, private sector) of the applicant concerned.

+

6.4.10 There are timelines for the assessment of the applications. + Within 21 working days

50

6.4.11 An internal tracking system is established to follow the targeted timeframes (statutory or not).

-

6.4.12 A written license, signed by a person with the adequate delegation, is sent to the applicant, including conditions or restrictions attached to the licence (validity and renewal).

+


6.5.1 There is enough personnel (internal and external) with adequate expertise (education, experience and training) for the assessment of the applications for and issuing of licences.

+

6.5.2 There is adequate office and storage space and the equipment for licensing.

-



6.6.1 There is a list/data base of all licensed importers, exporters, wholesalers and distributors.

+

6.6.2 The NRA retains a site master file of each premise licensed, including the approved changes with the supporting documentation. This file contains at least the following types of information: company, name and contact details, key personnel, premises address, equipment, list of drugs supplied (if adequate). All exemptions are documented in this file.

+


6.7.1 The list/data base of all the licensed importers, exporters, wholesalers and distributors is published and is publicly available.

-

6.7.2 The list/data base of all the licenses withdrawn, suspended or refused for importers, exporters, wholesalers and distributors is published and is publicly available.

-

MODULE 7 LICENSING PHARMACIES AND RETAIL OUTLETS COMMENTS:

7.1 Legal basis

7.1.1 The legislation requires that pharmacies and retail outlets or prospective pharmacies and retail outlets of pharmaceutical products to hold a licence.

+ Law on Licensing, Law on Health

7.1.2 There is a legal provision for licensing internet pharmacy or retailers. - No internet pharmacy

7.1.3 The legislation enables the NRA to issue a licence for a pharmacy, a retail outlet or an internet pharmacy, to suspend it for a period of time and to withdraw it.

+

7.1.4 The legal provisions require the retailers, sellers or dispensers to comply with the applicable Good Dispensing Practices or Good Pharmacy Practices.

+ MNS 5260-11 “Basic requirement of pharmacy”

7.1.5 The legal provisions require the notification of the NRA of significant changes/variations to the initial license.

-

7.1.6 There is a legal provision for at least one qualified responsible person for each pharmacy and retail outlet .

+ MNS 5260-11 “Basic requirement of pharmacy”


-

7.2 Guidelines

7.2.1 There are guidelines for pharmacies and retail outlets on the content of the application, the format and the procedure to follow when applying for a licence.

-

7.2.2 There are guidelines on waiving license requirements/ procedures/ steps.

-

51

7.2.3 There are guidelines for applicants on the definition of the types and scopes of variations and the documentation required.

-

7.2.4 There are guidelines for pharmacies and retail outlets on the Good Dispensing Practices or Good Pharmacy Practices.

-

7.2.5 There are guidelines on the appointment and qualification of the responsible person.

-



- At local level

7.3.2 Decentralized activities to other agencies/authorities follow the standards, guideline and procedures as agreed/decided with the central authority..

-


-


-

7.4 Licensing assessment procedures

7.4.1 A documented procedure is implemented for meetings with applicants and other interested parties.

-

7.4.2 Documented procedures/ standard checklists are implemented to assess applications for licensing.

-

7.4.3 Documented procedures are implemented for waiving certain requirements or steps.

± On meeting protocol

7.4.4 Documented procedures are implemented for assessing the applications for the variation of licences.

-

7.4.5 Documented quality control measures are in place such as peer-review.

+

7.4.6 Documented procedures are implemented for decision-making and for the issuance of the licences.

+

7.4.7 A documented procedure is implemented to issue the licence in a standardized format

+

7.4.8 The same criteria are used for licensing regardless of the affiliation (e.g. public, private sector, NGO) of the applicant concerned.

+

7.4.9 There are defined timelines for the assessment of applications. + Within 21 working days

7.4.10 An internal tracking system is established to follow the targeted time frames (statutory or not).

-

7.4.11 A written license, signed by a person with the adequate delegation, is sent to the applicant, including conditions or restrictions attached to the licences (validity and renewal).

+


7.5.1 There is enough personnel (internal and external) with adequate expertise (education, experience and training) for the assessment of the applications and for issuing of licences.

- 1 staff for drug affairs works at Health Department of Ulaanbaatar

7.5.2 There is adequate office and the storage space. -



7.6.1 There is a list/data base of all licensed pharmacies and retail outlets. + www.ubhealth.mn Journal of Drug

http://www.ubhealth.mn/

52

information

7.6.2 The NRA retains a site master file of each premise licensed, including the approved changes with the supporting documentation. This file contains at least the following types of information: name, key personnel, premises address, list of drugs approved for dispensing/sale (if adequate). All the exemptions are documented in this file.

+


7.7.1 The list/data base of all the licensed pharmacies and retail outlets is published and is publicly available.

+ www.ubhealth.mn Journal of Drug information

7.7.2 The list/data base of all the licenses for pharmacies and retail outlets withdrawn, suspended or refused is published and is publicly available.

+ www.ubhealth.mn Journal of Drug information

MODULE 8 REGISTRATION OF PHARMACY PERSONNEL COMMENTS:

8.1 Legal basis

8.1.1 There is a legal requirement for a person not to practise as a pharmacist unless his/her name has been registered by a Regulatory Authority.

+ 25 article of Law on Health, Health Minister’s Order N280, 2011

8.1.2 There is a legal requirement for a person not to practise as a pharmaceutical technician unless his/her name has been registered by a Regulatory Authority.

+ 25 article of Law on Health, Health Minister’s Order N280, 2011

8.1.3

There are legal requirements for the pharmacists and the pharmaceutical technicians to perform their duties in accordance with a code of ethics of the pharmaceutical profession.

+ Health Minister’s Order N135, 2006

8.1.4

There are legal requirements defining the necessary criteria that must be met regarding the pharmaceutical qualification and the experience for a pharmacist.

-

8.1.5 There are legal requirements defining the necessary criteria that must be met regarding the pharmaceutical qualification and experience for a pharmaceutical technician.

-

8.2 Pharmaceutical Practice Committee

8.2.1

There is a legal provision for the establishment of a Pharmaceutical Practice Committee (PPC).

+ Health Minister’s Order 360/2011

8.2.2 The composition of the PPC is clearly defined. + Health Minister’s Order 360/2011

8.2.3 The mission, responsibilities and powers of the PPC are clearly defined and include in particular: • the issuance of standards of practice and conduct, • the setting of standards of education and training for pharmacists and pharmaceutical technicians.

-

8.3 Disciplinary Committee

8.3.1 There is a legal provision for the establishment of a Disciplinary Committee (DC).

+ Health Minister’s order 135, 2006

8.3.2 The composition of the DC is clearly defined. + Health Minister’s order 135, 2006

8.3.3 The mission, responsibilities and the powers of DC are clearly defined and include in particular: • the issuance of a reprimand or a warning, • the recommendation to suspend or to remove a registered pharmacist or a registered technician from the respective register.

+ Health Minister’s order 135, 2006



53

8.4 Guidelines

8.4.1 There is a guideline on the content, the format of the applications and the procedure to follow for the registration: • as a pharmacist • as a pharmaceutical technician.

-


8.5.1 Registration activities are organized and performed at a central level of the country.

+

8.5.2

Decentralized activities to other agencies/authorities follow the standards, guideline and procedures as agreed/decided with the central authority.

+

8.5.3

In case of decentralization, a mechanism of exchange of information is established and implemented in order for the decentralized organization to receive requests and/or directives from the central authority and to report to it.

-


-

8.6 Registration procedures

8.6.1 Documented procedures are implemented for assessing the applications for registration and for issuing the licenses and renewal: • as a pharmacist • as a pharmaceutical technician.

+

8.6.2 This procedure considers in particular a continual professional education

+


8.7.1

There is enough personnel (internal and external) with adequate expertise (education, experience and training) for the assessment of the applications for registration of pharmacy personnel.

+

8.7.2 There is adequate office and the storage space. -

8.7.3 The equipment is adequate and well maintained for regulatory activities.

-


8.8.1 A list/data base of all registered pharmacists and technicians is established and kept up-to-date.

± Healthnet, but not works since 2010

8.8.2 The NRA retains a file of each registered pharmacist and pharmaceutical technician containing at least the following types of information: name, place of exercise, diploma or qualification and contact details.

+


8.9.1 The list/data base of all the registered pharmacists and technicians is published and is publicly available.

+ www.doh.gov.mn

MODULE 9 POST MARKETING SURVEILLANCE AND CONTROLS COMMENTS:

9.1 Import and export controls 9.1.1 The legal provisions require the importer to hold a marketing

authorisation or to have its pharmaceutical products registered before organising the importation activities.

+ 7.22 article of Law on Drug and Medical Devices

9.1.2 The legal provisions require the importers/exporters to hold an authorization for each importing and exporting act of a pharmaceutical product.

+ 7.22 article of Law on Drug and Medical Devices Health Minister’s order N344, 2011

9.1.3 The legal provisions require the importers and exporters to register + 15 article of Law on


54

information on the origin and the destination of the products imported and exported.

Drug and Medical Devices

9.1.4 There are guidelines for importers and exporters on the format and content of the application and the procedure to follow for these authorizations.

-

9.1.5 The activities are organized and performed at a central level of the country by the NRA.

+

9.1.6

Decentralized activities to other agencies/authorities follow the standards, guideline and procedures as agreed/decided with the central authority.

+




-

9.1.9 Documented procedures are implemented in the NRA to assess the application for import and export certificates/authorizations.

+

9.1.10 Documented procedures are implemented to issue import and export certificates/authorizations, in standardized formats.

+

9.1.11 There are records or a data base kept by the RA on imported and exported products.

+

9.1.12 There is a collaboration/agreement with the Customs or other enforcement agencies on the control of import and export.

9.2 Market Controls

9.2.1 There are legal provisions to deal with non-compliant products. + Law on Drug and Medical Devices, Law on State Inspection,

9.2.2 There is a legal provision for sampling and testing samples of pharmaceutical products on the market.

+ Law on standardization and conformity

9.2.3 Documented procedures are implemented to sample the products sold or supplied on the market and to send them for testing to the drug control quality laboratory.

-

9.2.4 The criteria for sample collection are based on risk assessment. - 9.2.5 There are provisions and criteria for compensation for the samples

collected. -

9.2.6

The activities are organized and performed at a central level of the country.

-

9.2.7

Decentralized activities to other agencies/authorities follow the standards, guidelines and procedures as agreed/decided with the central authority.

+


-


-

9.2.10 Documented procedures/programs are implemented for collecting information, detecting and combating non-compliant products.

-

9.2.11 A market surveillance strategy based on inspection activities, control -

55

activities and other information is established and implemented under the format of surveillance program for example.

9.2.12 A surveillance program (quality control plans and sampling strategy) is established to cover various dosage forms of different drug/medicinal products and is based on the potential health risks identified or expected for the patients.

-

9.2.13

The strategy and the surveillance program are periodically reviewed and its effectiveness is assessed.

-

9.2.14

The RA keeps the records or information/data base on the samples collected of non-compliant products.

-

9.2.15 A collaborative agreement with the Customs and other enforcement agencies is established for market control activities, in particular for sharing information and exchanging best practices.

-

9.2.16 A documented procedure is implemented for communication/collaboration and cooperation with the relevant authorities/jurisdiction in the investigations and the prosecution of breaches of regulation.

-

9.3 Non-compliant products and recall procedures

9.3.1 The legislation enables the RA to instruct for the recall of pharmaceutical products (e.g. due to defects, inappropriate labelling or packaging or contamination ).

-

9.3.2 The legislation enables the RA to suspend or stop the manufacture, import, export, distribution, sale or use of pharmaceutical products.

-

9.3.3 There is a legal requirement for records to be maintained within the distribution chain to ensure batch traceability and facilitate an effective recall system.

-

9.3.4 There is a legal provision concerning the disposal of defective/non-compliant products.

-

9.3.5 There is a legal requirement for manufacturers/importers to notify the NRA before initiating a recall and upon request to inform on the progress.

-

9.3.6 There is a legal requirement for manufacturers/importers to notify the NRA about product complaints regarding quality.

+ Law on standardization and conformity

9.3.7 There are guidelines for manufacturers, importers, exporters and distributors on how to organise a recall and to organise the disposal of defective/non-compliant products.

-

9.3.8 Documented procedures are implemented in the NRA to assess the notification of recalls and product complaints.

-

9.3.9 Documented procedures are implemented in the NRA to ensure the removal of defective products, organize an effective recall and disposal of defective/non-compliant products.

-

9.3.10 There are defined criteria to determine the appropriate means and the level of communication of a recall with a feedback mechanism.

-

9.3.11 The effectiveness of the recall system is regularly validated. - 9.3.12 There is guidance on the mechanism to ensure that appropriate

actions (including destruction when necessary) have been taken. -

9.3.13 The NRA approves the closure of a recall and certifies the disposal of defective/non-compliant products.

-

9.3.14 The NRA keeps the records or an information/data base on recalled and disposed defective/noncompliant products.

-

MODULE 10 CONTROL OF DRUG PROMOTION AND ADVERTISING

56

10.1Legal basis

10.1.1 There are legal provisions for the control of promotion of

pharmaceutical products to avoid communication of false or

misleading information.

+ Article No 26.7 of the Law on Drug and Medical Devices and articles No 13, 24.1 and 24.6 of the Law on Advertisement.

10.1.2 The legal provisions allow, under certain conditions and criteria, the promotion of the pharmaceutical products to the general public

+ Law on Drug and Medical Devices (article No26.2 and 26.3) and the Law on Advertisement (article No6.2, 13.1, 13.3 and 13.4)

10.1.3 The legal provisions allow under certain conditions and criteria the promotion of pharmaceutical products to those persons qualified to prescribe, supply or dispense these products.

-

10.1.4 The legislation enables the NRA to grant the authorization of marketing products, to suspend and to withdraw it or to stop any promotional campaign and to cease the distribution of promotional documents.

+ article No 6.2 and 24.6 of the Law on Advertisement.

10.1.5 The legal provisions prohibit the distribution of free samples of pharmaceutical products to the general public for promotional purposes.

-

10.1.6 The legal provisions allow under certain conditions the distribution of free samples of pharmaceutical products to those persons qualified to prescribe, supply or dispense these products.

-

10.1.7 The legal provisions require the medical or sales representatives to have adequate scientific knowledge and training.

-

10.1.8 The legal provisions require to use the approved product information (e.g. SPC) as reference materials to monitor promotion and advertising activities and materials.

+ Article № 27.3 of the Law on Drug and Medical Supply

10.1.9 The same legal provisions are applicable to the promotion of pharmaceutical products on internet.

-

10.1.10

The legal provisions prohibit the supply, offer or promise to persons qualified to prescribe, to supply and to dispense the pharmaceutical products any gift, pecuniary advantage or benefit of any kind unless strict conditions are met.

+ The article No 11.1.6 of the law on Drug and Medical Device

10.2 Guidelines

10.2.1 There are guidelines on the content, the format of the application and the procedure to follow for receiving the approval of promotional and advertising material.

-

10.2.2 There are guidelines on the control of advertisements and promotion during symposiums and other scientific meetings.

-

10.2.3 There are guidelines on the control of the operations of Medical and Sales Representatives

-


10.3.1 Promotion and advertisement authorization activities are organized + DOH

57

and performed at a central level of the country.

10.4 Internal procedures

10.4.1 Documented procedures are implemented in the NRA to assess and to approve promotional and advertising materials.

-

10.4.2 Documented procedures are implemented in the NRA to review any complaints received regarding medicine promotion and advertising activities

-

10.4.3 External experts are involved in the assessment of the applications for promotion and advertising authorization.

-

10.4.4 An advisory committee of experts is involved in the review of the applications for promotion and any matters related to the control of drug promotion.

+ The application and other submitted materials for the drug advertising permission are reviewed by the Pharmacology sub Committee.

10.4.5 The NRA has developed a proactive monitoring program to check advertisement and promotions in scientific journals or literature for healthcare practitioners

-

10.4.6 Civil Society groups, professional associations and NGOs are involved in detecting unethical promotion and advertising activities.

-

10.4.7 The Inspectorate staff is involved in the detection of unethical or unauthorized promotional and advertising materials.

+ GASI and The Unfair Competition Regulatory Authority

10.4.8 The NRA staff responsible for issuing MAs of pharmaceutical products is involved in the assessment of the applications for the promotion of pharmaceutical products and any investigations on promotional activities.

-

10.5 Human and other resources .

10.5.1 There is enough personnel (internal or external) with the adequate expertise for the assessment of the applications, for issuing the approvals and for implementing the surveillance program.

-

10.5.2 There is adequate office and storage space -


-

10.6

Records and outputs

10.6.1 The RA keeps the records or information / data base on approved and refused promotional material and advertisements with the supporting documentation.

± DOH keep the records of approved and refused applications. But the information was not included in any of the databases of the organization.


10.7.1 The list of authorized promotional materials and advertising campaigns is published and is publicly available.

www.doh.gov.mn not updated from


58

2011 April content of information not adequate.

10.7.2 The list of unauthorized and unethical promotional materials and advertising campaigns is published and is publicly available

-

MODULE 11 PHARMACOVIGILANCE COMMENTS

11.1 Legal basis`

11.1.1 There are legal provisions on post marketing safety monitoring of pharmaceutical products

+ Article 6.1, 6.2.1 Law of Drug and Medical device and part 26

11.1.2 The legal provisions require the NRA to implement a vigilance system in order to collect the information useful in the surveillance of medicines, to evaluate such information and to take the appropriate decisions.

+ MOH order 378/2010

11.1.3 There are legal provision for all stakeholders to report adverse reactions/event or any safety issues to the NRA under defined conditions.

± MOH order 378/2010

11.1.4 There are legal provisions for MA holders that require the registration, data collection and maintenance, assessment and monitoring of adverse reactions/event and to report to the NRA on these activities.

-

11.1.5 The legal provisions require the manufacturers, distributors, importers, exporters to report the adverse reactions/events to the MAH and NRA under specific conditions.

+ Article 2.12 of MOH order 378 /2010

11.1.6 The legal provisions requires the healthcare professionals to report any adverse events/reactions to MA holders or to the RA or another delegated authority

+ Part 2 of MOH order 378/2010, report to DOH

11.1.7 There are specific requirements for reporting safety issues related to specific categories of products (e.g. vaccines, biologicals, biological products, etc).

-

11.1.8 There are specific requirements for Marketing authorization holders, manufacturers, importers, exporters, distributors, wholesalers to designate a qualified person in charge of post Marketing Authorization safety monitoring.

-

11.1.9 There are legal provisions to define the terminology used such as adverse event, adverse reaction, serious adverse event, etc.

± Adverse reaction, serious adverse event not defined

11.1.10 The legal provisions specify the delay and/or the periodicity for reporting of adverse events

Article 2.11 MOH order 378 /2010

11.1.11 There are specific requirements for health care institutions (clinics, hospitals, etc..) to designate a focal person for post marketing safety monitoring

+ Medicine therapeutic committee of tertiary and secondary hospitals designated

11.2 11.2 Guidelines

11.2.1 There are guidelines on post MA safety monitoring regarding the registration, the reporting and the format to be used (initial report, periodic reporting).

+ Article 2.3 of MOH order 378 /2010

11.2.2 There are guidelines on classification of safety events. -

11.2.3 The guidance on safety reporting provides for a scientific +

59

evaluation of the risk/benefit balance of medicines.

11.2.4 There are guidelines defining the adequate scientific knowledge and training of qualified persons and focal persons in charge of vigilance.

-

11.2.5 There are guidelines on the criteria to determine the reporting timelines and means of reporting of safety events (serious, expected, etc…).

-


11.3.1

Vigilance activities are organized and performed at a central level of the country.

+ DOH

11.3.2 Decentralized activities to other agencies/authorities follow the standards, guideline and procedures as agreed/decided with the central authority.

+


+


-

11.4 Internal procedures

11.4.1 External information (information sources and reference materials) for decision making on ADR and safety monitoring are readily available.

-

11.4.2 Documented procedures are implemented in the NRA to register and to assess day to day ADR reports.

±

11.4.3 A documented procedure is implemented to follow implementation of pharmacovigilance plan (see also module 4 on MA)

-

11.4.4 Documented procedures are implemented in the NRA to analyse the safety trends for signal detection.

-

11.4.5 A well-established system is in place for prioritization of drug safety signals according to the public health impact and to demonstrate that high risk issues are investigated immediately or in the first instance.

-

11.4.6 External experts are involved in the assessment of the information on safety transmitted through the vigilance network.

-

11.4.7 An advisory committee of experts is involved in the review of the information on safety transmitted through the vigilance network and any other matters related to the safety of pharmaceutical products.

+ Pharmacology sub committee

11.4.8 There are defined timelines for the assessment and decision making on ADR.

-


-

11.4.10 Documented procedures are implemented for decision-making and for defining the recommended actions to be taken by the NRA, by the MAH, by the manufacturer or any other stakeholders

-

11.4.11 There are documented quality control measures in place such as peer-review.

-

11.4.12 The NRA organizes on a regular basis campaigns to promote adhesion to vigilance

± MOH and DOH organized ADR training in 3 provinces

60

11.4.13 Consumers and patients are involved in the safety monitoring program.

±

11.4.14 The NRA has developed a proactive monitoring program to check compliance of the MAH to applicable regulatory requirements and best practices.

-

11.4.15 MAH, manufacturers, importers, exporters, distributors are periodically inspected by inspectorate on pharmacovigilance practices.

-


11.5.1 There is enough personnel (internal or external) with adequate expertise (education, experience and training) for safety monitoring activities.

-

11.5.2 There is adequate office and storage space. ±


±


11.6.1 The information collected on safety is used for making or amending regulatory decisions on initial MA (adding information on SPC, restricting the use of drug, review of PIL, recall or withdrawal of products, etc.).

-

11.6.2 The NRA keeps the information/data base on safety events reported and on the actions taken. The terminology used is the one promoted by the WHO (WHO-ART)

-

11.6.3 Query tools on the data collected enables the NRA to assess and interpret safety signals( calculation of incidence rate, assessing of causality)

±


11.7.1 Information on ADR and safety monitoring measures taken are communicated to the public, including the safety notice.

-

MODULE 12 CLINICAL TRIALS COMMENTS

12.1 12.1 Legal basis

12.1.1 12.1.1 There is a legal provision for the authorization, suspension and withdrawal of clinical trials by the NRA or by another delegated authority for pharmaceutical products.

+ MOH order 223/2007 annex 1

12.1.2 There is a legal provision requesting the establishment of IRB/IEC. + Article 26,1 law on Health, Medical Ethical Committee

12.1.3 There is a legal provision requesting an ethics opinion of an IRB/IEC.

+ MOH order 223/2007 annex 1guidline 2

12.1.4 The legal provisions require the notification and approval of the NRA of significant changes/variations to the initial clinical trial protocols.

+ MOH order 223/2007 Annex 1

12.1.5 The legal provisions require the investigational/research centres to comply with Good Clinical Practices and Good Laboratory Practices.

± Accredited hospitals and laboratory

12.1.6 There are legal provisions on licensing of manufacturers and importers of investigational products.

-

61

12.1.7 These is a legal provision requiring the products for investigation to comply with the applicable GMP.

-

12.1.8 There are legal provisions on specific labelling and packaging requirements for the investigational products.

-

12.1.9 There are legal provisions requiring authority for the importation and exportation of investigational products.

-

12.1.10 There are legal provisions requiring during the conduct of a clinical trial, the notification, data collection, assessment and monitoring of adverse drug reactions/events and to report to the NRA under specific conditions.

+ MOH order 223/2007 Annex 8

12.1.11 There are legal provisions defining the terminology used, for clinical trial purpose, such as adverse event, adverse reaction, serious adverse event, unexpected, etc.

+ MOH order 223/2007 Annex 8 6.1, 6,2

12.1.12 Legal provisions specify the delay and/or the periodicity for reporting of adverse events during the clinical trial.

+ MOH order 223/2007 Annex 8 6.1, 6,2

12.1.13 There are exemptions to clinical trial requirements following defined criteria

-

12.2 Guidelines

12.2.1 There are guidelines for sponsors or sponsors representatives on the content of the application, the format and the procedure to follow in order to submit an application for conducting clinical trials.

+ MOH order 223/2007 Annex1, guideline 2,3,6

12.2.2 There are guidelines for applicants on the types and scopes of variations/amendments and on the documentation required.

+ MOH order 223/2007 Annex 8 4.1, 4,2

12.2.3 There are guidelines on conditions (e.g. validity, amendment of the protocol, etc) attached to the clinical trial approvals issued.

+ MOH order 223/2007 Annex 8 4.1, 4,2

12.2.4 There is a guideline on monitoring of adverse reactions (give details) and on periodical reporting of their results to the NRA.

+ MOH order 223/2007 Annex 8 6.1, 6,2

12.2.5 There is a guideline on the criteria for selecting the Principal

Investigator and his roles and responsibilities.

± MOH order 223/2007 Annex 1

12.2.6 There are guidelines for licensing manufacturers and importers of investigational products

-

12.2.7 There are guidelines on compliance with the GMP

requirements for the manufacturers of investigational products

-

12.2.8 A guidance for investigation centres/clinical trial sites provides

detailed information on compliance with GCP and GLP requirements. This guidance is in line with the WHO format

-

12.2.9 There are guidelines on the control of importation and exportation of investigational products

-

12.3 Ethical oversight

12.3.1 The ethical oversight established is based on the Declaration of Helsinki.

+ MOH order 223/2007

62

12.3.2 There is a requirement on the composition, functions and mode of operation of the IRB/IEC

+ MOH order 223/2007 annex 8 part 2

12.3.3 Documented procedures are implemented to review the trial in particular the clinical trial protocols and amendments, documented informed consent and recruitment procedure

± MOH order 223/2007 annex 8 part 4. Documentation not reviewed

12.3.4 There is a requirement on the establishment of an IRB/IEC supervising authority.

+ MOH order 223/2007 annex 8 part 2.1

12.3.5 The funding for IRB/IEC is based on the fees for the services provided.

_

12.3.6 There is an approval and supervisory system for IRB/IEC. -

12.3.7 A procedure details the review and the methodology used for the supervision of the IRB/IEC

+ MOH order 223/2007 annex 8 part 10 audit procedure

12.3.8 A general policy on potential conflicts of interest for members of IRB/IEC is established and implemented.


12.3.9 A general policy on confidentiality and a code of conduct for members of IRB/IEC is established and implemented


12.3.10 There is a documented mechanism to manage potential conflicts of interest of members of IRB/IEC by collecting declarations of interests, including ensuring updates of these declarations.

± MOH order 223/2007 annex 8 part 2.2 Documentation not reviewed

12.4 Organizational structure

12.4.1 The activities are organized and performed at a central level of the country

+ MOH Ethical Committee

12.4.2 Decentralized activities to other agencies/authorities follow the standards guideline and procedures as agreed/decided with the central authority

+ 5 Ethical Sub Committees. They follow the guidelines and rules developed by the Ethical Committee


-

12.4.4 The mechanisms in place allow exchange and harmonization of best practices appropriate cooperation and collaboration among the decentralized organizations.

-

63

12.5 Assessment procedures

12.5.1 Documented procedures are implemented for the assessment of CT applications.

NA

12.5.2 Documented procedures are implemented for assessing the application for amendments of CT protocols

NA

12.5.3 The Investigator’s Brochure, Informed Consent procedure, investigation plan, data collection tools are assessed and approved as part of the approval for the clinical trial

+

12.5.4 External experts are involved in the assessment of CT applications + MOH order 223/2007 annex 8 part 2.4

12.5.5 An advisory committee of experts is involved in the review of CT application and any other matters related to the research investigations on human being

+

MOH order 223/2007 annex 8 part 2.4

12.5.6 Documented procedures are implemented for decision-making on CT.

NA

12.5.7 The assessment report on the CT is fulfilled following a standardized format

NA

12.5.8 Documented procedures are implemented to ensure the involvement and communication between the assessors and the regulatory inspectorate for compliance to applicable good practices (GMP, GCP and GLP)

-

12.5.9 The NRA has developed a proactive monitoring program to check compliance with applicable regulatory requirements, applicable good practices and as per the authorization delivered.

-

12.5.10 IRB/IEC, investigators and sponsors are periodically inspected by the inspectorate of the DRA.

-

12.5.11 The same criteria are used for the evaluation of CT applications regardless of the origin of the request (e.g. domestic, foreign, public/private sector).

+ Additional ethical criteria of the medical research sponsored by foreigners

12.5.12 There are timelines for the assessment of CT applications. NA


NA

12.5.14 There is a fast-track mechanism for the assessment of CT applications for specific products of particular public health value

NA

12.5.15 A documented procedure is implemented to issue CT related authorization in a standardized format.

NA

12.5.16 A written authorization, signed by a person with the adequate delegation, is sent to the sponsor, including conditions or restrictions attached to this authorization.

NA


12.6.1 There is enough personnel with adequate internal and external expertise (education, experience and training) for the assessment of CT applications

NA

12.6.2 Manufacturer's or sponsor's representatives are never involved in the assessment of CT (at any level/stage including expert

NA

64

13.1.1 There is a legal provision to inspect premises where regulated

activities are performed in order to check compliance with the

applicable regulation good practices and standards.

+ Articles 10.9.1,

10.9.2 Law on

State inspection

and monitoring

13.1.2 There is a legal provision specifying the periodicity for regulatory

inspections.

+ Articles 51.3, 51.2

Law on State

inspection and

monitoring

13.1.3 There is a legal provision allowing the inspection of foreign sites of

manufacturers.

-

13.1.4 There is a legal provision designating the inspectors and their

powers.

+ Article 10 Law on

State inspection

and monitoring

13.1.5 The inspectors have adequate powers and authority to carry on

their missions.

+ Articles 10.9,

10.12 Law on

State inspection

and monitoring

13.1.6 There are exemptions to the inspection requirements with defined

criteria.

+ Risk assessment

criteria

13.1.7 The legislation provides for adequate and proportional sanctions,

penalties and prosecution upon conviction based on violation of the

applicable legislation.

+ Articles 16 Law

on State

inspection and

monitoring and

article 29 law on

Drug and Medical

committees).

12.6.3 There are lines of authority reflecting the independence of decision-making in the CT approval system from sponsors, investigators or government.

NA

12.6.4 There is adequate office and storage space. NA


NA

12.6.6 Adequate support services are provided in terms of communication, equipment and infrastructure.

NA


12.7.1 There is a list/data base of all the approved and rejected CT applications.

NA

12.7.2 The NRA retains a file of each CT approved and rejected, including the amendments approved or rejected and the supporting documentation which includes the summary assessment reports. All the exemptions to clinical trials requirements are documented.

NA


12.8.1 A list of CT approved and CT applications rejected, including the summary assessment reports is published and is publicly available.

-

MODULE 13 REGULATORY INSPECTIONS AND ENFORCEMENT ACTIVITIES

65

devices

13.2 Guidelines

13.2.1 There is a guidance on the compliance and enforcement strategy

taken by the NRA defining the pyramid of sanctions applicable

-

13.2.2 This enforcement strategy is based on voluntary decisions

regulatory measures (warning letter, cancellation of licence or

MA). (voluntarily stop sale, recall) and

-

13.2.3 There is a deadline for GMP, GCP, GLP and GDP compliance for

all domestic facilities (in case of recently adopted legal provisions).

- GMP 2011

13.2.4 There are guidelines for conducting pre- and post- licensing

inspections

-

13.2.5 There are guidelines for the environmentally-conscious disposal of

expired/unusable substances reagents and finished products.

+ the joint order

No249/201 of

Health Minister

and Nature,

Environment

Minister


13.3.1 Inspection activities are organized and performed at a central level

of the country

+ GASI, Drug

regulatory division

of DOH

13.3.2 Decentralized activities to other agencies/authorities follow

the standards, guideline and procedures as agreed/decided with

the central authority

+ The Inspection

Offices at aimag

and city district

level

13.3.3 In case of decentralization, a mechanism of exchange of

information is established and implemented in order for the

decentralized organization to receive requests and/or directives

from the central authority and to report to it.

-

13.3.4 The mechanisms in place allow exchange and harmonization

of best practices appropriate cooperation and collaboration among

the decentralized organizations

-

13.4 Quality management system

13.4.1 A quality management system is implemented for the inspectorate +

13.4.2 The management of the inspectorate is committed to the

development and implementation of the Quality Management

System, in particular providing financial and organizational support.

+

13.4.3 The quality management system is based on recognized

standards as reference(WHO PIC/S, ISO, other).

+ ISO 31000:10

13.4.4 The quality policy and related quality objectives of the Inspectorate

are defined and documented.

+

13.4.5 A qualified person is designated as responsible within the

inspectorate for the development and implementation of the

quality management system

+

13.4.6 The documentation needed to establish, implement and

maintain the QMS is defined(Quality manual, records, SOPs).

+

13.4.7 The documentation required by the QMS is controlled following a +

66

documented procedure

13.4.8 A documented procedure is established by the Inspection to

plan, and to assess if the QMS is effectively implemented and

conforms to planned arrangements

+

13.4.9 The Inspectorate performs internal audit of its QMS at least once every 12 months. Records of the

results are maintained.

+

13.4.10 The corrective and preventive actions taken as a result of audits or

from any other non conformity are implemented and documented.

Their effectiveness is checked and documented

+

13.4.11 The top management of the inspection reviews on a regular basis,

at least once every 12 months the QMS to evaluate its efficiency

as well as its effectiveness Records of the review are

maintained

+

13.5 Internal planning and procedures

13.5.1 The inspectorate establishes compliance monitoring programs

based on activities that are supervised (GMP, GDP, GCP,

Pharmacy, Retail outlets, etc…).

+ Checklist

13.5.2 Documented procedures/tools are implemented for the planning of

inspection activities showing in particular the duration and

frequency of the inspections.

+

13.5.3 The internal planning for inspection activities is established and

updated to cover all regulated activities.

+

13.5.4 Documented procedures/tools are implemented for the

preparation and the development of adequate materials for an

inspection (check-list, reference materials, plans, etc…).

+

13.5.5 Documented procedures/tools are implemented to perform the

inspections and in particular on assessing the critical steps of the

processes and validation

+

13.5.6 Documented procedures/tools are implemented to check

compliance with the GMP, GDP, GCP, GLP, Good vigilance

practices and good dispensing practices.

-

13.5.7 Documented procedures are implemented for inspections based

on specific requirements for specific classes of products and

facilities (generics, sterilisation, innovator products).

+

13.5.8 There is a standard format for reporting inspection gaps or

deficiencies such as an inspection report.

+

13.5.9 The observations of non compliance are classified/categorized

according to the risk (critical, major and minor).

+

13.5.10 Documented quality control measures are in place such as peer-

review.

-

13.5.11 External experts are involved in the inspection processes. -

13.5.12 A committee of internal experts within the DRA is involved in the

inspection, evaluation of the inspection reports and in decision-

making

-

13.5.13 Documented procedures are implemented for decision-making. +

13.5.14 Documented procedures are implemented for follow-ups on

deficiencies/violations to enforce compliance (including

timeframes) and to issue notices on the violations

+

13.5.15 Documented procedures are implemented on investigation

activities, any seizure or prosecution.

+

67

13.5.16 Documented procedures are implemented to ensure the

adequate involvement and communication between the

inspectors, QC laboratory staff and licensing or registration staff.

+

13.5.17 The same criteria are used for the inspection of domestic, foreign,

public and private facilities.

+

13.5.18 There are time limits for the publication of Inspection reports. +

13.5.19 An internal tracking system is established to follow the targeted time

frames (statutory or not).

+

13.5.20 A documented procedure is implemented to issue Good

Practices related certificates in a standardized format

-


13.6.1 Job descriptions are established for the following staff: head of

the inspectorate (supervisor) head of the inspection unit by

products, inspection team leader and inspector

+

13.6.2 There is enough personnel (internal and external) with adequate

expertise (education experience and training) for the inspection of

all, pharmaceutical products and regulated activities such as

• manufacturers of active pharmaceutical ingredients,

• manufacturers of finished pharmaceutical products,

• pharmaceutical quality control laboratories

• importers and exporters,

• wholesalers and distributors,

• Institutions for conducting clinical and non-clinical trials,

• Pharmacies and retail outlets

• MA Holders.

±

13.6.3 The minimum qualification, experience and training for

performing all kinds of inspections is defined

±

13.6.4 The inspectors have the knowledge of the local judiciary

procedures if they are supposed to initiate actions in the courts of

justice

-

13.6.5 There is a documented process on qualification and review to

confirm the competencies required for being inspectors.

-

13.6.6 A documented procedure is implemented for the designation of

inspectors

+

13.6.7 The inspectors are trained on the specific areas (GMP, GDP,

GCP, and GLP).following a training program. The training

activities are recorded and such records are kept up-to-date

-

13.6.8 Manufacturer's or license holder's representatives are never used

to conduct inspections

-

13.6.9 The list of inspectors that are qualified with their specific areas of

competencies is available and is kept up-to-date

-

13.6.10 There is adequate office and storage space for the inspectorate’s

activities.

±

13.6.11 The equipment is adequate and well maintained for regulatory

activities.

±

13.6.12 Adequate support services are provided in terms of transport and

communication

-


13.7.1 There is a list/data base of all inspected facilities. +

13.7.2 The NRA retains a file of each inspection including the information

on the mission, the inspection report, the comments of the

+

68

company inspected and the final decision taken with supporting

documentation Each exemption is documented in this file.

13.7.3 The information collected on the company is used for making or

amending regulatory decisions on initial licenses or MA (Recall or

withdrawal of products, etc).

+


13.8.1 The list and identity of the designated inspectors is available to

the companies subjected to inspection

+

13.8.2 The list/data base of all the inspected facilities is published and is

publicly available.

+

13.8.3 A summary of the inspection reports are published and are

publicly available, following applicable local confidentiality

requirements

-

13.8.4 The information regarding the enforcement activities such as

notices of compliance penalties, prosecutions engaged are

published and are publicly available

-

MODULE 14 QUALITY CONTROL LABORATORY COMMENTS

14.1 Legal basis

14.1.1 There is a legal provision for the establishment of a

Regulatory Quality Control Laboratory (RQCL).

+ Parliament

Resolution

No58Goverment

resolution

162/2000

14.1.2 The RQCL is part of the NRA. +

14.1.3 There is a legal provision on the designation of analysts and

their powers.

+ Chair Order of the

Laboratory

14.1.4 The legislation empowers a RQCL to perform quality

control testing of the pharmaceutical products and to issue

official results

+ Article 13,2 Law on

standardization

and conformity

14.2 Guidelines

14.2 There is a defined policy for testing in the pre-marketing and

post-marketing period.

Article 6.2.1Law on

drug and medical

devices

14.2.2 There are guidelines on collection, packaging and submission

of samples.

+ Government

Resolution No 39

(2004/04/11) on

collection of

samples and State

Inspectorate

Agency Chair

Order No 35

14.2.3 There are guidelines on the references or standards applied by

the RQCL

+ Quality manual

book

14.2.4 There are guidelines on how to complain and appeal against

the decisions of the RQCL.

+ Standardization

and Meteorology

69

agency

accreditation

procedure


14.3.1 Testing activities are organized and performed at a central level

of the country

+

14.3.2 Decentralized activities to other agencies/authorities follow

the standards, guidelines and procedures as agreed/decided

with the central authority

NA

14.3.3 In case of decentralization, a mechanism of exchange of

information is established and implemented in order for the

decentralized organization to receive requests and/or directives

from the central authority and to report to it.

NA

14.3.4 The mechanisms in place allow exchange and

harmonization of best practices appropriate cooperation and

collaboration among the decentralized organizations.

NA

14.4 Quality management system

14.4.1 A quality management system is implemented for the RQCL. +

14.4.2 The management of the RCQL is committed to the

development and implementation of the Quality Management

System, in particular providing financial and organizational

support

+

14.4.3 The quality management system is based on recognized

standards as reference (WHO PIC/S, ISO, other).

+ MNS ISO/IEC

17025:2007

14.4.4 The quality policy and related quality objectives of the RQCL

are defined and documented

+ Quality policy and

13 objectives were

defined

14.4.5 A qualified person is designated as responsible within the

RCQL for the development and implementation of the quality

management system.

+

14.4.6 The documentation needed to establish, implement and

maintain the QMS is defined(Quality Manual, records, SOPs

±

14.4.7 The documentation required by the QMS is controlled following

a documented procedure

±

14.4.8 A documented procedure is established by the RQCL to

plan and to assess if the QMS is effectively implemented,

and conforms to planned arrangements

±

14.4.9 The RQCL performs internal audit of its QMS at least once

every 12 months Records of the results are maintained

+

14.4.10 The corrective and preventive actions taken as a result of

audits or from any other non conformity are implemented and

documented. Their efficacy is checked and documented

+

14.4.11 The RQCL is regularly audited by an external organization(e.g.

certification, accreditation) and the results are available.

+ Standardization

and Meteorology

agency

70

accreditation

14.4.12 The RQCL participates in a proficiency testing scheme

and in external quality assurance programs

±

14.4.13 Top management of the RQCL reviews on a regular basis, at

least once every 12 months the QMS to evaluate its efficiency

as well as its effectiveness. Records of the review are

maintained

+ Administration

analysis meeting

14.5 Quality control procedures

14.5.1 Documented procedures are implemented for meetings with

clients and other interested parties

+

14.5.2 Documented procedures are implemented for preparation and

storage of standards, samples, etc.

±

14.5 . Documented procedures are implemented for performing the

testing.

±

14.5.4 There is appropriate planning of testing and maintenance

activities

±

14.5.5 Documented procedures are implemented for handling and

storage of in-coming and retention samples.

+

14.5.6 Documented procedures are implemented for testing specific

ranges of products.

NA

14.5.7 There are specific documented procedures to deal with non-

compliant products

±

14.5.8 There are strategies, programs and procedures for the

introduction and validation of new/improved tests.

+

14.5.9 Documented procedures are implemented for the evaluation of

test results and decision-making.

+

14.5.10 Documented procedures are implemented for handling out-of-

specification results including a retesting policy

+

14.5.11 There is a standard format for recording and reporting results of

analysis (work sheet and CoA).

+ Work sheet

14.5.12 Documented procedures are implemented for follow-ups of

non- compliant products to enforce compliance (including

timeframes

±

14.5.13 The same criteria are used for testing all products from

domestic, foreign, public and private facilities.

+

14.5.14 A documented procedure is implemented to issue certificates in

a standardized format.

+

14.6 Human resources

14.6.1 Job descriptions are established for the following staff: head of

RQCL (supervisor Analysts, storekeeper and reference

material coordinator

+

71

14.6.2 There is enough personnel (internal and external) with

adequate expertise (education experience and training) for the

testing of

• Active pharmaceutical ingredients

• Pharmaceutical products,

• Biological,

• Traditional/Herbal medicines

±

14.6.3 There are mechanisms to manage any conflicts of interest,

including ensuring updates of declarations of conflicts of

interest

-

14.6.4 There are mechanisms to ensure that confidentiality

requirements are met, for example by the observance of a code

of conduct by the analysts

±

14.7 Infrastructure and equipment

14.7.1 There is adequate working space, work environment and

storage space for laboratory activities

-

14.7.2 Equipment and instruments for testing activities are adequate

and well maintained.

-

14.7.3 Documented procedures are implemented for the correct use of

the equipment according to the manufacturer[s instruction

-

14.7.4 There are operation manuals and logs books for the

equipment (registers of

operations/use/maintenance/calibration)

±

14.7.5 Plans for cleaning, calibration and maintenance activities are

established and implemented

-

14.7.6 There are qualification protocols and reports for the equipment. ±

14.7.7 There are adequate support services provided in terms of

transport and communication.

-

14.8 Reference standards/materials and reagents

14.8.1 There is a system to establish and qualify the national

reference standards/materials.

-

14.8.2 There is a regular supply system for reference

standards/materials.

±

14.8.3 Documented procedures are implemented for the

appropriate handling and use of reference

standards/materials

±

14.8.4 Documented procedures are implemented for sourcing,

preparation storage and use of reagents of assured quality.

±

14.9 Safety programme

14.9.1 A list of hazardous substances is available and updated ±

14.9.2 The responsible staff is designated for the management of a

safety programme

-

72

14.9.3 A documented procedure are implemented for the storage,

handling and disposal of hazardous substances.

±

14.10 Sub-contracting

14.10.1 A list of all the categories of testing activities the NDCL sub-

contacts to another laboratory or organization is established

NA

14.10.2 A formal agreement/contract defines the roles and

responsibilities of each stakeholder in particular as regards

conflict of interest and confidentiality

NA

14.10.3 A documented procedure is implemented to ensure that the

requirements that apply to the NDCL are also applied in the

same way to the sub-contracting organization

NA


14.11.1 There is a list/data base of all the products tested +

14.11.2 Testing records/reports are maintained and are readily

available at the RQCL

±

14.11.3 The RQCL issues certificates of analysis under its own name or

in the name of the NRA.

+ Issued its own

name

MODULE 15 CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND

PRECURSORS

15.1.1 The country is a signatory to the International Conventions on the control of Narcotics, Psychotropic Substance and their Precursors

+

15.1.2 There are legal requirements for manufacturing, importing, exporting, storage, distribution, and consumption of Narcotics, Psychotropic Substances and their Precursors.

+ The parts 4 to 8 of

the Law on

Narcotics

Psychotropic

Substance Control

15.1.3 There are legal requirements for reporting, reconciliation and disposal of Narcotics, Psychotropic Substances and their Precursors

+ The part 8, 9 of the

Law on Narcotics

Psychotropic

Substance

Control.

15.1.4 There are guidelines on the formats for permits, for advice of receipt and for submission of returns of the controlled substances.

+ Part 4 of the order

regulates advice

of the receipts and

part 7 stated

submission of

returns forma

15.1.5 These activities are organized and performed at a central level of the country.

+ MOH and DOH

15.1.6 Decentralized activities to other agencies/authorities follow the standards, guidelines and procedures as agreed/decided with the central authority

+ Department of

health in the UB

and provinces.

73


-


-

15.1.9 There is a specific requirement for institutions to designate a focal person for the control of Narcotics, Psychotropic Substances and their Precursors in each facility using or utilizing these substances.

-

15.1.10 Documented procedures are implemented to evaluate the returns for quantification and detection of abuse or diversion.

+

15.1.11 There is enough personnel (internal and external) with adequate expertise (education, experience and training) for control of narcotics, psychotropic substances and their Precursors.

-

15.1.12 The civil society and healthcare professional are involved in the activities for the control of Narcotics, Psychotropic Substances and their Precursors

±

15.1.13 There are defined reporting timelines and means of submitting returns on these substances

+ Article 9.1 of the

Law on Narcotics

Psychotropic

Substance

Revolving Control

15.1.14 15.1.14 There is information/data base on consignments received and returns submitted for these substances.

± MOH, GASI, State

Police Office and

State Custom

Office each have

their own

information

database on

movement of

those drugs and

substances.

15.1.15 Any abuse or diversions and actions taken are registered and documented by DRA.

± GASI and State

Police Office

register and

document any

abuse or

diversions and

actions taken.

MOH does not

collect and receive

above mentioned

information.

74

15.1.16 Information sources and reference materials on the control of Narcotics, Psychotropic Substance and their Precursors are readily available

-

MODULE 16 INTERNATIONAL COOPERATION AND HARMONISATION

16.1.1 There is an internal policy to facilitate international cooperation and harmonization.

+ Parliament Resolution No 68 on Approval of Drug Policy in 2002,article 5.2

16.1.2 There are agreements signed between the DRA and RA of other countries or agencies for cooperation and harmonization

± Germany, Korea,

Turkey, Poland

16.1.3 The NRA participates or follows the development of International and/or Regional standards

± MOH do use the international and regional standards However, MOH do not participate in the development process of the international and regional standards

16.1.4 The NRA participates or follows any harmonization initiative or forum.

+ MOH

16.1.5 The NRA participates in working groups within the harmonization initiative or forum for regulators

±

16.1.6 The NRA recognizes and/or uses regulatory decisions, reports (inspection, evaluation, and vigilance), guidance or information from other NRAs or international bodies.

+ MOH recognizes and uses regulatory decisions, reports inspection, evaluation, (vigilance), guidance which were approved by WHO.

16.1.7 The NRA recognizes and uses the WHO recommended certification schemes and formats.

+ WHO guideline, the requirements of GMP, CCP, BCPP certificates were included in the regulatory document.

16.1.8 The NRA issues CPP certificates following a documented procedure.

-

16.1.9 The Inspectorate participates in peer-reviewed or joint activities (e.g. PIC/S).

-

16.1.10 The RQCL participates in proficiency testing schemes, regional collaborative studies or the WHO External Quality Assurance Assessment Scheme (EQAAS).

-

16.1.11 The NRA participates in the WHO Drug Safety Monitoring Programme.

+ Uppsala

Monitoring centre

16.1.12 The NRA participates in INCB’s international monitoring +

75

operations on control of Narcotics, Psychotropic Substances and their Precursors.

16.1.13 The NRA participates in coordinating activities/measures in case of identification of non-compliant products at a regional/international level.

-

16.1.14 Documented procedures are implemented to ensure satisfactory cooperation, collaboration and exchange of information with other RA for the various regulatory functions (MA, Inspection Vigilance).

-

76

Annex 2 List of organizations visited and list of persons met

Meeting with the Ministry of Health (MOH)

Munkhdelger Ch, Head of Division of Pharmaceuticals and Medical Devices

Amarjargal Ch, Division of Pharmaceuticals and Medical Devices, Officer in Charge

of policy coordination for quality and safety of medical devices

Chuluunzezeg D, Division of Pharmaceuticals and Medical Devices, Officer in Charge

of policy coordination for the proper usage of pharmaceuticals.

Tuya B, Division of Foreign relationship, Officer in Charge of policy coordination for

bilateral relations and cooperation in the health sector

Burmaajav B Strategic Policy and Planning Department of Officer in Charge of

science and technology policy planning.

Meeting with Department of Health Government Implementing Agency

Uranchineg M, Deputy Director, in charge of drug regulation

Uranchineg D, Officer in charge of standardization

Zuzaan Z , Officer in charge of ADR

Munkhtuul T, Officer in charge of drug information and advertisement

Bolortuya Ts, Officer in charge of Drug registration

Tsetsensanaa G, Officer in charge of Import authorization

Munkhtsetseg B, Officer in charge of Licensing

Dondogmaa, Officer in charge of registration of medical personal

Meeting with State Professional inspection Agency

Altantuya D, Senior Inspector of drug and bio preparation.

Tumendemberel D, Officer of risk assessment.

Meeting of Central Quality Control Laboratory

Mr Amar B, Head of QC central joint laboratory

77

Mrs.Ulziidulam D, Senior Analyst, QC laboratory

Mrs. Munkhtuya. B Quality manager

Meeting with Drug Reference Laboratory

Zorig T, Head of drug reference laboratory

Meeting with QC laboratory of Pharmacy School, Health Sciences University of

Mongolia

Surenmandakh G, Quality manager and analyst

Meeting with the Authority for Fair Competition and Consumer Protection of

Mongolia

Munguntseteg T, Department of consumer protection, inspector in charge of

advertisement

Meeting with Criminal Police Department of Mongolia

Ulziibayar G, Officer in charge of narcotics psychotropic substance control

78

Annex 3 References:

1. Laws and policy papers

Law on Health (July 7, 1998)

Law on Medicines and Medical Devices (May 27, 2010)

Law on Advertisement (May 30, 2002)

Law on State Inspection Law (Jan 03,2003 amended in June 10, 2010)

Law on Narcotics Psychotropic Substance Revolving Control (Oct 28, 2002 and amended in May 26, 2011).

Law on Consumer protection (Dec 26, 2003)

Law on State Employment (June 28, 2002)

Law on Government Agency ( April 15, 2004)

Law on Licensing (Feb 01, 2001)

Law on standardization and conformity (May 15, 2003)

Law on Public Service (June 28,2002 amended in March 28, 2009)

National Drug Policy (Oct 11, 2002) Government resolution

Some implementation issue of the Law on Narcotics Psychotropic Substance Revolving Control Government resolution No 196 ( 2003)

HMO 306/2003

HMO 378 /2010

HMO 223/2007

HMO 278/2011

HMO 252/2008

HMO 360/2011

HMO 344/2011

HMO 280/2011

HMO 402/2011

HMO 38/2007

The joint order No249/201 of Health Minister and Nature, Environment and

Tourism Minister.

MNS 5530-2009 “Basic requirement of Drug suppliers”

MNS 5524-2011 “Basic requirement of Drug manufacturers”

MNS 5260-11 “Basic requirement of pharmacy”

2. Web sites

www.moh.mn

www.doh.mn

www.inspection.mn

www.afccp.gov.mn

www.estandart.mn

www.masm.gov.mn

http://www.moh.mn/

http://www.doh.mn/

http://www.inspection.mn/

http://www.afccp.gov.mn/

http://www.estandart.mn/

http://www.masm.gov.mn/

79

3. Books and journals

WHO Data Collection Tool for the Review of Drug Regulatory Systems, WHO. 2007

Practical Guidance for Conducting a Review. WHO. 2007

Handbook Medical ethics MOH Mongolia WHO Edited by B.Burmaajav, Kh.Damdinjav 2011

Drug information Bulletin number 1(56) 2011 published by DOH Mongolia



80

Annex 4. Quantitative indicators for regulatory purposes

Module 3 - Regulatory Authority

QI 3.1 Total number of the NRA's employees at the end of a reference year 9

QI 3.2 Number of the NRA's scientific staff performing regulatory functions 0

QI 3.3 Number of the NRA's support staff 0

QI 3.4 Number of the NRA's staff IT specialist 0

QI 3.5 Number of the NRA's staff involved in QMS 0

QI 3.6 Number of the NRA's staff recruited in the reference year 2

QI 3.7 Number of the NRA's staff's cancellation in the reference year 0

Module 4 - Marketing authorization

QI 4.1 Number of scientific staff involved in the registration process 0

QI 4.2 Number of products with a valid Marketing Authorization 2476

QI 4.3 Total number of applications received in the reference year 936

QI 4.4 Number of applications received for a new drug in the reference year 237 /registered/

QI 4.5 Number of applications received for a generic product in the reference year 35 /registered/

QI 4.6 Number of applications received for variations in the reference year 261

QI 4.7 Number of applications received for renewal in the reference year 64

QI 4.8 Number of decisions taken (positive, refusals, suspension) in the reference year 272

QI 4.9 Number of applications pending as backlog 3

QI 4.10 Average number of days for decision-making on a new drug 90

QI 4.11 Average number of days for decision-making on a generic product 90

QI 4.12 Average number of days for decision-making on variations 30

QI 4.13 Average number of days for decision-making on renewals 30

Module 5 - Licensing of manufacturer

QI 5.1 Number of scientific staff involved in establishment licensing 0

QI 5.2 Number of manufacturing plants licensed 30

QI 5.3 Number of manufacturing plants of API licensed 0

QI 5.4 Number of applications received for a new premise in the reference year 1

QI 5.5 Number of modifications of an initial license received in the reference year 1

QI 5.6 Number of decisions taken (positive negative, suspension or withdrawn) in the reference year

5


QI 5.8 Average number of days to issue a decision 21

Module 6 - Licensing of importers, exporters, wholesalers and distributors


QI 6.2 Number of licensed wholesalers, importers and exporters Drug -147 Medical Device -139 /geminated/

QI 6.3 Number of licensed wholesalers, importers and exporters of API 30



QI 6.6 Number of decisions taken (positive, negative, suspension or withdrawn) in the reference year

39



Module 7 - Licensing of pharmacies and retail outlets /In Ulaanbaatar/


81

QI 7.2 Number of licensed pharmacies and dispensing/selling outlets 530



QI 7.5 Number of decisions taken (positive, negative, suspension or closed) in the reference year

42


QI 7.7 Average number of days to issue a decision 21 working days

Module 8 - Registration of pharmacy personnel

QI 8.1 Number of administrative staff involved in registration of pharmacy personnel 1

QI 8.2 Number of pharmacist and pharmaceutical technicians registered 2987

QI 8.3 Number of application received in the reference year 1428

QI 8.4 Number of decisions taken (positive, negative, suspension or radiation) in the reference year

728


Module 9- Market surveillance

Import and export Control since Dec

QI 9.1 Number of application received (import and export) 2664

QI 9.2 Number of authorizations for importation granted in the reference year and/or number of product authorized for importation

2656

QI 9.3 Number of certificates for export issued in the reference year 2

QI 9.4 Average number of days to issue these administrative document 5

Market Control

QI 9.5 Number of products monitored 0

QI 9.6 Number of products detected as non-compliant or of poor quality in the reference year

0

Non-compliant Products / Recall Procedures

QI 9.7 Number of complaints on pharmaceutical products received in the reference year

0

QI 9.8 Number of products/batches recalled in the reference year 0

Module 10 Control of drug promotion

QI 10.1 Number of staff involved in the control of drug promotion 5

QI 10.2 Number of drugs advertisement applications received in the reference year 53

QI 10.3 Number of promotion and advertisement document monitored 53

QI 10.4 Number of decisions taken (approbations, refusals, suspensions) on drug advertisement in the reference year

53

QI 10.5 Average number of days for decision-making on drug promotion 14

QI 10.6 Number of drug advertisements found to be in violation of the regulation and withdrawn in the reference year

13

Module 11 - Pharmacovigilance

QI 11.1 Number of NRA's professionals involved in the assessment and management

of ADR/ADE

5

QI 11.2 Number of contact points (moral or physical person having sent an ADR/ADE) 0

QI 11.3 Number of ADR/ADE reported by MAH. Manufacturers, importers or distributors

and assessed in the reference year

0

QI 11.4 Number of ADR/ADE reported by health professional/contact point and

assessed in the reference year

33

QI 11.5 Number of ADR/ADE reported by patients and assessed in the reference year 0

82

QI 11.6 Number of periodic report received and assessed in the reference year 21

QI 11.7 Number of decisions taken (no action taken, product recall, Dear doctor letters,

notices for users, etc…)in the reference year

0

QI 11.8 Number of ADR/ADE reported pending as backlog NA

QI 11.9 Average number of days for decision-making on pharmacovigilance issues NA

Module 12 - Clinical trial

QI 12.1 Number of staff involved in the control of Clinical trial 3

QI 12.2 Number of clinical trials applications received in the reference year 5

QI 12.3 Number of applications for amendments of clinical trials received in the

reference year

1

QI 12.4 Number of decisions taken (approvals, refusals, suspensions) on clinical trials

applications in the reference year

6

QI 12.5 Average number of days for decision-making for NRA 0

QI 12.6 Average number of days for decision-making for IRB/IEC 45

QI 12.7 Number of staff involved in the inspection of clinical trials 3

QI 12.8 Number of clinical trials inspected in the reference year

QI 12.8 Average number of days spent on-site per inspection 3

Module 13 - Regulatory Inspection and enforcement activities

QI 13.1 Total number of inspectors for the pharmaceutical products sector 35

QI 13.2 Total numbers of inspections carried out in the reference year 845

QI 13.3 Number of manufacturing inspectors 12

QI 13.4 Number of manufacturing facilities inspected including foreign manufacturers in

the reference year

0

QI13.5 Number of manufacturing facilities inspected for pre-approval inspection for

marketing authorization

0

QI 13.6 Number of manufacturing facilities of API inspected in the reference year

0

QI 13.7 Average number of days spent on-site per manufacturing inspection 3

QI I 13.8 Number of importers, exporters, wholesalers and distributors inspectors 31

QI 13.9 Number of wholesale/import/export facilities inspected in the reference year 77

QI 13.10 Number of wholesale/import/export facilities of API inspected in the reference

year

0

QI 13.11 Average number of days spent on-site per wholesale/import/export inspection 3 days if have a branch 5 days

QI 13.12 Number of inspectors for retail facilities 31

QI 13.13 Number of retail facilities inspected in the reference year 770

QI 13.14 Average number of days spent on-site per retail facility inspection 1-2

QI 3.15 Number of facilities inspected on pharmacovigilance in the reference year 26

QI 13.16 Average number of days spent on-site per facilities inspected on

pharmacovigilance

1

83

QI 3.17 Number of administrative measures (notice of non compliance or warning

letters) issued in each of the last three years

1

QI 3.18 Number of license withdrawn or suspended in each of the last three years for

noncompliance issues

14 withdrawn 30suspended

QI 13.19 Number of criminal prosecution submitted to court and/or penal sanctions

requested in each of the last three years

In 2011 2 criminal persecution requested

QI 13.20 Number of legal sanctions applied by the judiciary in each of the last three

years

NA

Module 14 - Quality Control

QI 14.1 Number of pharmaceutical products tested in the framework of an application

for a MA in the reference year

249

QI 14.2 Number of active pharmaceutical ingredients tested in the framework of an

application for a MA in the reference year

48

QI 14.3 Number of pharmaceutical products tested for import control in the reference

year

505

QI 14.4 Number of pharmaceutical products tested for market control in the reference

year

201

QI 14.5 Number of pharmaceutical products tested/certificate issued in the reference

year

1715

QI

14.5.1

Number of pharmaceutical products tested and failed to be compliant 253

QI 14.6 Number of pharmaceutical products recalled based on the results issued by

DCL in the reference year

10,5 million

tugrug

medical

devices and

drugs have

been

recalled

QI 14.7 Number of MA suspended or withdrawn based on the results issued by DCL in

the reference year

QI 14.8 Number of scientific staff in the Quality Control laboratory 15

QI 14.9 Surface of the Quality Control laboratory 240 sq.m

QI 14.10 Number of analysis not performed because of lack of adequate equipment 20

84

Annex 5 Organogram of Drug Regulatory organizations of

Mongolia

85

Annex 6 Action plan Date: 2011.12.24

Country: Mongolia

Name of Drug Regulatory Authority: Division of Drug Regulation, DOH-GIA

Prepared by: Purevsuren S, Munkhdelger B, Uranchimeg M

Recommendations

Objective to be

achieved

Main tasks / activities to be

performed

Timeframe Responsible

person

Resources

required

Improve law implementation,

and develop policy, plan and

regulation needed for regulatory

activity

Enforce law

implementation

Improve monitoring of law

implementation

2012- I MOH, DOH,

GSAI

Develop policy, plan and

regulation needed for

regulatory activity

Renew the regulations used for

regulatory activities

2012- I MOH, DOH,

GSAI

Develop regulations missed for

regulatory activity

2012- II MOH, DOH,

GSAI

Provide the power and autonomy

of Regulatory Authority and

increase funding, human and

other resources. Strength Drug

Regulatory Functions.

Improve autonomy of

NMRA

Establish an independent Drug

Regulatory Agency

2013- I MOH Financing

Establish an Institutional Development

Plan, Vision and the Mission Statement

and implement.

2012- I DOH

Establish indicators to monitor/assess

progress towards the objectives.

2012- I DOH

Develop documented policy to avoid the

accumulation of responsibilities for

regulatory activities with the same

authority/individuals.

21012-I DOH

Improve infrastructure of

Regulatory organizations

Enhance work space and improve work

environment

2013-1 MOH Financing

Provide the equipment for performing

the regulatory functions and support

services (transport and communication)

2012-IV DOH Financing

Develop staff Develop policy on human development 2012-I DOH

86

Establish an initial and periodic staff

appraisal system

2012-II DOH

Take advantage of external

experts and involve them

in the regulatory processes.

Set up advisory committees of experts

involved in the regulatory processes of

the NMRA.

2013 – I DOH

Develop a written policy for the

recruitment and the designation of

external experts and members of experts

committees calling for candidates,

defining the review by a selective

jury/panel, appointments and publishing

of the final decision but also to cross off.

2012 -III DOH

Strength Drug Regulatory

Functions

Involve an advisory committee in

regulatory activity

2012-IV DOH

Improve legal environment for drug

regulation and the capacity of drug

regulatory organizations

2012-III DOH

Improve the coordination of

organizations involved in drug

regulatory activity

2012-I DOH

Improve information

management systems and

Communication activities of

Regulatory system. Establish the

mechanism of information and

practice exchange and

implement.

Improve information

management system

Use computerized systems for

automation of repetitive functions and

for reporting activities

2012-I DOH

Establish an integrated network of all

computers related to regulatory

functions.

2012-I DOH

Documented procedures are in place to

gather data and use the software

applications as well as query tools.

2012-I DOH

Improve communication

activity

Establish information and

communication strategy to maintain

confidence in the regulations and to

provide timely, necessary and helpful

information.

2012-II DOH

Prepare a crisis plan for coping with

major incidents and information that

could potentially alarm the public.

2012-II DOH

87

Establish Quality Management

System in Drug regulatory

system and implement WHO

guidelines and ISO standards.

Ensure that the local drug

organizations comply with WHO

GP guidelines.

Establish and implement a

Quality Management

System for all the

regulatory processes

Define quality policy and related quality

objectives

2012-II DOH

Establish, implement and maintain the

quality manual, records, SOPs

2012-III DOH

Establish and implement documented

procedure in regulatory activity

2012-I DOH

Establish and implement internal audit,

peer-review and internal tracking system

2012-III DOH

Implement WHO

guidelines and ISO

standards Ensure that the

local drug organizations

comply with WHO GP

guidelines.

Develop guidelines needed for

regulatory activity

2012-2013 DOH

Implement the GP assessment for local

drug organizations

2013-2014 DOH

Use the same criteria for evaluation of

MA applications

2013 DOH

Improve the quality, efficacy and

safety of medicines. Establish a

post marketing surveillance and

pharmacovigilance activities

Establish a post marketing

surveillance

Develop market surveillance strategy 2012-II DOH

Improve a collaborative agreement with

the Customs and other enforcement

agencies

2012-I DOH

Establish a

pharmacovigilance

Develop a proactive monitoring program

to check compliance of the MAH to

applicable regulatory requirements and

best practices

2012-II DOH

Organize a regular basis campaigns to

promote adhesion to vigilance

2013-I DOH

Involve consumers and patients in the

safety monitoring program.

2012-II DOH

Inspect periodically MAH,

manufacturers, importers, exporters,

distributors on pharmacovigilance

practices.

2012-III DOH

Improve the cooperation with

UPPSALA center

2012-II DOH

Improve the activity of Drug therapeutic

committee of tertiary and secondary

hospitals

2012-II DOH

Improve impartiality, Improve transparency and

confidentiality

Develop the declarations on interests of

staff and internal and external experts as

2012- III DOH

88

transparency and monitoring and

accountability of Drug

Regulatory organizations and

stakeholders.

well as members of technical/advisory

committee

Involve the industry, consumers and

patients’ representatives as observers in

technical/advisory committee meetings.

2012 -II DOH

Establish a competent contact person or

a public relations unit

2012 -II DOH

Improve accountability of

Drug Regulatory

organizations

Provide requirements for monitoring and

accountability of the NRA by

stakeholders.

2012-II DOH

Review the regulatory processes are

regularly and systematically in order to

identify problems, gaps and

inconsistency within the regulatory

authority.

2012-II DOH

Develop a policy paper to expand

the international relationship.

Enroll as a member of the

international organizations

working in the drug and

biologically active products.

Develop a policy paper to

expand the international

relationship

Develop internal policy to facilitate

international cooperation and

harmonization.

2012-II DOH

Establish cooperation with RA of other

countries or agencies

2012-II DOH

Establish a cooperation with

international professional and scientific

association and centers, such as PIC/S

2012-III DOH

Enroll as a member of the international

organizations

2012-III DOH

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