Assessment African Countries
Transcript of Assessment African Countries
Assessment of medicines regulatory systems in sub-Saharan African countries An overview of findings from 26 assessment reports
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Assessment of medicines regulatory systems in sub-Saharan African countries
An overview of findings from 26 assessment reports
WHO/EMP/QSM/2010.4
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Assessment of medicines regulatory systems in sub-Saharan African countries
An overview of fi ndings from 26 assessment reports
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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ContentsAcknowledgements ......................................................................................................................................2
Abbreviations ....................................................................................................................................................3
Executive summary ..................................................................................................................................... 4
1 Introduction ...............................................................................................................................................6 1.1 Medicines regulation in developing countries ................................................................................................................................ 6
1.2 Overview of regulatory elements ......................................................................................................................................................... 6
1.3 Aim of this report ....................................................................................................................................................................................... 7
2 Method .........................................................................................................................................................7
3 Results ..........................................................................................................................................................8 3.1 Country profi les ........................................................................................................................................................................................... 8
3.2 Regulatory framework .............................................................................................................................................................................. 9
3.3 Structure and management .................................................................................................................................................................12
3.4 Medicines registration (marketing authorization) ......................................................................................................................13
3.5 Licensing of activities ..............................................................................................................................................................................16
3.6 Import and export control .....................................................................................................................................................................16
3.7 Inspections ...................................................................................................................................................................................................17
3.8 Quality control ...........................................................................................................................................................................................18
3.9 Market surveillance (product quality monitoring, pharmacovigilance, control of promotion and advertising) ......... 18
3.10 Oversight of clinical trials ......................................................................................................................................................................20
4 Conclusions ............................................................................................................................................... 21
Annexes ........................................................................................................................................................... 22 ANNEX 1: Geographical, socio-economic and pharmaceutical indicators ..................................................................................22
ANNEX 2: Organizational structure and implementation of regulatory functions ..................................................................24
ANNEX 3: Organizational structure and management ........................................................................................................................26
ANNEX 4: Marketing authorization..............................................................................................................................................................28
ANNEX 5: Licensing of activities ....................................................................................................................................................................31
ANNEX 6: Import control ..................................................................................................................................................................................32
ANNEX 7: Inspections ........................................................................................................................................................................................34
ANNEX 8: Quality control .................................................................................................................................................................................36
ANNEX 9: Market surveillance ........................................................................................................................................................................38
References ........................................................................................................................................................41
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This report summarizes the fi ndings of 30 assessments of regulatory systems carried out by assessment teams on behalf of WHO’s Department of Essential Medicines and Pharmaceutical Policies (EMP). The countries visited are listed in Annex 1 of this report. WHO would like to thank the governments of these countries, and the respondents during the assessment visits, for their cooperation and support.
The assessments were conducted by the following experts on behalf of WHO: Dr Adebowale Adeoye (WHO/DFID), Dr Abubakr Abdelraouf Alfadl (Sudan), Mr Mohamed Imadin Atabani (Sudan), Mr Benjamin Botwe (Ghana), Mrs Kari Bremer (Norway), Dr Andrew K. Chemwolo (Kenya), Mr Felix Peter Chizu (Zambia), Dr Mory Fofana (Guinea), Mrs Mariama Gamatie, Mr Ishmael Joseph, Mr Rutendo Kuwana (Zimbabwe), Mrs. A. C. Madukwe (Nigeria), Mr Einar Magnusson (Iceland), Ms. Gugu N Mahlangu (Zimbabwe), Dr Minkaila Maiga (Mali), Mr Deus Mubangizi (Uganda), Dr Anastasie Mulumba (WHO), Mr Viateur Mutanguha (Rwanda), Dr Margareth Ndomondo-Sigonda (Tanzania), Professor Tamás Paál (Hungary), Dr Alain Prat (WHO), Dr Nicole Ridolphi (France), Mr. Adetona Saka (WHO/DFID), Dr Burhani Othman Simai (Zanzibar), Mr Hiiti Sillo (Tanzania), Dr Stanley Soyona (EAC), Dr Ogori Taylor (Nigeria), Professor Amor Toumi (WHO), Dr Jean-Marie Trapsida (WHO-
AFRO), Professor Charles Wambebe (WHO/DFID) and Mr Eshetu Wondemagegnehu (WHO).
The Swedish International Development Cooperation Agency (SIDA) and the European Commission (EuropeAid Co-operation Offi ce) provided fi nancial support for the assessment visits.
Dr Alain Prat further improved the WHO data collection tool for the assessments as well as a detailed guidance document for its use, building on the pioneering work of Eshetu Wondemagegnehu and Dr Valerio Reggi (WHO). He also prepared a background document synthesizing the main fi ndings of 21 country assessments and giving conclusions based on his experience as a member of nine of the missions and from his ongoing work in assisting the regulatory authorities of the countries assessed.
Mrs Monika Zweygarth prepared the draft report. Dr Alain Prat, Dr Samvel Azatyan, Dr Amor Toumi and Dr Lembit Rägo provided valuable input.
Acknowledgements
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Abbreviations
API Active pharmaceutical ingredient
BCS Biopharmaceutical Classifi cation System
BE Bioequivalence
CIOMS Council of International Organization of Medical Sciences
COA Certifi cate of analysis
CPP Certifi cate of pharmaceutical product
CTD Common technical document
DMF Drug Master File
EAC East African Community
EMEA European Medicines Agency
FPP Finished pharmaceutical product
GCP Good Clinical Practices
GDP Good Distribution Practices
GMP Good Manufacturing Practices
GLP Good Laboratory Practices
GSP Good Storage Practices
ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals forHuman Use
ISO International Organization for Standardization
MA Marketing authorization
MoH Ministry of Health
NMRA National medicines regulatory authority
NGO Non-governmental organization
OECD Organization for Economic Co-operation and Development
OTC Over-the-counter
PQP Prequalifi cation Programme (WHO)
PV Pharmacovigilance
QA Quality assurance
QC Quality control
SOP Standard operating procedure
SPC Summary of product characteristics
UMC Uppsala Monitoring Centre (WHO Collaborating Centre for International Drug Monitoring hosting Global Database of Adverse Drug Reaction reports)
US FDA United States Food and Drug Administration
USA United States of America
WHO World Health Organization
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Executive summary
Medicines regulation is needed to ensure that all pharmaceutical products on the market are safe, effective and consistently meet approved quality standards [1].
WHO works with Member States in assessing national regulatory systems to identify gaps, develop strategies for improvement and support countries in their commitment to build national regulatory capacity.
This report synthesizes the fi ndings of rapid assessments performed at national medicines regulatory authorities (NMRAs) in 26 African countries over the last eight years. It is mainly based on the reports provided to the countries by the assessment teams. Although the emphasis of the missions was on capacity-building rather than a standardized comparison of indicators, the fi ndings are thought to give a reasonable overview of the regulatory situation in Africa at the time of the visits.
1. Country profiles
Most of the countries visited had limited economic resources as well as a high burden of illness, limited pharmaceutical manufacturing capacity and a diverse pharmaceutical supply chain.
2. Regulatory framework
Strengths: All countries had legal provisions in place which designated an NMRA and defi ned its main functions. Several countries were committed to giving their NMRAs more autonomy in terms of management and funding.
Weaknesses: The legal framework was complex, with unclear defi nitions of responsibilities, resulting in regulatory gaps and overlaps. Some NMRAs were not fully established. In many countries not all regulatory functions were operational.
3. Structure and management
Strengths: Overall, countries showed increasing awareness of the importance of independence, impartiality and transparency in medicines regulation. Many staff members were motivated and professional despite diffi cult working conditions.
Weaknesses: Most NMRAs lacked sustainable funding. There was a universal shortage of qualifi ed staff and operational resources. Quality Management Systems covering regulatory procedures, specifi c development programmes to keep staff abreast of current
technology and science, and specifi c measures to assure confi dentiality and to avoid confl icts of interest were generally absent.
4. Medicines registration (marketing authorization)
Strengths: The majority of countries had a legal basis for medicines registration in place, and had drafted supporting documents for applicants and for assessors. Advisory committees were widely used, and to a certain extent expertise of external assessors was sought for medicines registration.
Weaknesses: Guidelines and assessment procedures were not up to WHO standards, and were often of an administrative rather than technical nature. There were wide-ranging exemption clauses not justifi ed by a risk assessment, for example for public sector imports or donations. There were few mechanisms in place to ensure the impartiality and technical competence of external assessors. Scarce resources severely limited technical assessment of dossiers. In spite of resource constraints few countries relied on decisions made by other regulators such as stringent NMRAs or by the WHO Prequalifi cation Programme. Regulatory decisions by other competent authorities were not widely recognized.
5. Licensing of activities
Strengths: Countries generally had legal provisions for licensing pharmaceutical activities, including manufacturing, wholesale, import/export, distribution and retail sale.
Weaknesses: Licensing was not implemented effi ciently. This function was not under the sole control of the NMRA in most cases, and some of the authorities involved had no technical capacities. Poor coordination and poor information management resulted in regulatory gaps.
6. Import and export control
Strengths: In most countries, only medicines with marketing authorization were eligible for import.
Weaknesses: Systems to verify the marketing authorization or exemption status of products on importation were ineffi cient or absent in many countries. There was poor coordination among the authorities involved. Mechanisms to control exported medicines were either absent, or not stringently enforced.
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7. Inspections
Strengths: Structures existed to inspect pharmaceutical establishments for compliance with national guidelines.
Weaknesses: This function was often shared with other authorities, and inspections were not well coordinated. Guidelines were not in line with WHO standards for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Lack of qualifi ed inspectors, transport and communication severely limited the number and quality of inspections conducted.
8. Quality control (QC)
Strengths: The majority of countries had a regulatory QC laboratory. Most laboratories had qualifi ed staff, and many had adequate, serviceable equipment. Several laboratories were committed to implementing a QMS.
Weaknesses: Few laboratories had an effective QMS in place. QC testing was not used optimally to complement other regulatory functions.
9. Market surveillance (product quality monitoring, pharmacovigilance, control of promotion and advertising)
Strengths: Most countries had some legal provisions and structures in place to monitor the safety, effi cacy and quality of medicines on the market.
Weaknesses: Implementation of post-marketing surveillance was poor. Quality monitoring was not prioritized based on risk, but was generally performed in case of complaints if at all. Few countries monitored adverse events to medicinal treatment or controlled promotion of pharmaceuticals systematically. Generally speaking, market surveillance measures were not suffi ciently integrated with other regulatory activities.
10. Oversight of clinical trials
Strengths: The majority of countries had provisions in place to control ethical aspects of clinical trials.
Weaknesses: Few NMRAs authorized the performance of clinical trials in their countries, and therefore very few authorities monitored clinical trials after approval. Links with ethics committees were often weak or non-existent. GMP was not assured for investigational products.
Conclusion
Structures for medicines regulation existed in the countries assessed, and the main regulatory functions were addressed, although in practice the measures were often inadequate and did not form a coherent regulatory system. Common weaknesses included a fragmented legal basis in need of consolidation, weak management structures and processes, and a severe lack of staff and resources. On the whole, countries did not have the capacity to control the quality, safety and effi cacy of the medicines circulating on their markets or passing through their territories. Regulatory capacity should be built urgently in African countries, using the following approaches:
Encourage and assist countries to assess their own •
regulatory systems in a systematic way in order to identify and address gaps.
Work towards consistent implementation of all •
essential regulatory functions in African countries, based on the key provisions in the existing legal frameworks.
Strengthen management structures, specifi c technical •
regulatory expertise and physical resources (both human and fi nancial) available to NMRAs in Africa.
Consider mechanisms for sharing the outcomes of •
regulatory assessments.
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Medicines regulation in 1.1 developing countries
Medicines are essential to health care and must be available to the inhabitants of every country. Medicines regulation aims to ensure that medicines on national markets and in international commerce are safe, effective and of good quality, are accompanied by complete and correct product information, and are manufactured, stored, distributed and used in accordance with good practices.
Affordable products are increasingly becoming available which have the potential to reduce morbidity and mortality in resource-constrained countries dramatically. African countries import most of their pharmaceuticals. However, recently the African Union has started to promote local manufacture of medicines in Africa.
The increasing globalization of commerce and the merging of pharmaceutical companies are breaking down national boundaries in medicines supply. Substandard and counterfeit pharmaceutical products have been reported from all over the world [2]. The problem is greatest in developing countries, which have insuffi cient funds for medicines procurement, and even fewer resources to enforce quality standards and to protect the medicines supply chain.
The norms and standards for medicines quality are becoming more and more sophisticated. The assessment of new chemical entities is especially challenging. International norms and standards for medicines are thus more important than ever before. WHO continues to develop such norms and standards to serve as guidance for national regulatory systems. In practice however, quality standards of medicines are often adapted to the requirements in force in the destination country [3].
Regulating the increasingly complex channels of medicines supply requires constant vigilance, adaptation and considerable organizational capacity and resources. WHO’s constitutional mandate requires it to support member states in implementing regulatory mechanisms to international norms and standards. This report presents the results of assessments of regulatory systems conducted in 26 sub-Saharan African countries (24 belonging to the WHO AFRO region) over the last eight years to identify regulatory gaps and to suggest priority activities to strengthen regulatory capacity.
Overview of regulatory 1.2 elements
A host of challenges threatens the safety, effi cacy and quality of medicines at every stage of their life cycle: Weaknesses in research and development, defi ciencies in dosage form design, varying standards in ongoing production, damage during transport and storage, and inadequate use of products by prescribers and patients. An effective system must therefore provide the full range of regulatory functions, covering every stage of the cycle.
The main functions of an NMRA include control of pharmaceutical products by registration and post-marketing surveillance (quality monitoring and pharmacovigilance), as well as control of activities by licensing and inspection of manufacturers, importers, exporters, wholesalers, distributors, pharmacies and retail outlets, control of clinical trials and control of promotion of pharmaceuticals. These functions must work together to form a coherent medicines regulatory system (see Figure 1).
FIGURE 1: ALL FUNCTIONS OF A MEDICINES REGULATORY SYSTEM
Control of preclinical and clinical trials (GCP, GLP, GMP) for new chemical entities
Control of products Control of activitiesLicensing of manufacturer (GMP)
Product registration:Marketing authoriza-tion (MA) (based on evaluation of quality, safety, efficacy)
Quality Control (QC)(based on specifications)
DDEVELOPMENT
USEPharmacovigilance(monitor safety/efficacy of products)
Market surveillance(product quality)Monitoring of activities
Control of advertising(check claims against approved SPC)
DISTRIBUTIONLicensing of importer, wholesaler, distributor (GDP, GSP), pharmacy (GPP)
Control of import/export (based on MA)
Inspection
MANUFACTURE / IMPORT
Anti-counterfeiting programme
African pharmaceutical markets are mostly generic markets. The main difference between the life cycles of originator and generic medicines is in the development phase. While for innovator medicines the focus is on safety and effi cacy data (proven in preclinical and clinical trials), generic medicines are assumed to be safe and effi cacious if they are proven to be interchangeable with originators, and the focus is essentially on quality.
Introduction1.
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Aim of this report1.3
This report aims to give an overview of the legal basis, structures, processes and implementation of medicines regulation in African countries. 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 Africa.
Objectives
The objectives of this report are:
to highlight the main strengths and weaknesses • of medicines regulation in African countries;
to put the fi ndings into the context of the •
global regulatory situation and of internationally recommended standards for effective medicines regulation; and
to provide a baseline and perspective for future •
assessment strategies.
Method2.
The assessments summarized in this report were conducted during visits to NMRAs conducted in the period from 2002 to 2009 at countries’ offi cial request to WHO. These requests were motivated by sub-regional initiatives, collaborative projects for a situation analysis, and/or countries’ willingness to strengthen national regulatory systems. Assessments included in this report were performed in 26 African countries. Four countries were visited twice; in these cases the most recent fi ndings were taken into account.
The assessments were conducted by teams composed of WHO experts, staff from NMRAs and/or external consultants, acknowledged at the beginning of this report.
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 country’s regulatory functions, most visits took approximately three to fi ve working days.
Data were collected by interviewing personnel, reviewing documents (manuals, records, reports, fi les), analysing
data and/or observing activities. Findings were recorded on a comprehensive data collection tool developed by WHO [4], which was later complemented by a detailed guidance document [5]. A 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 fi ndings where necessary.
In order to respect countries’ confi dentiality rights, countries are identifi ed only by randomly assigned numbers in Sections 3.2 - 3.10 and in Annexes 2 -10. Countries are grouped into four geographic sub-regions of Africa (East, West, Middle, South1); Sudan as the only country of the North region has been included in the East region. Sub-units of NMRAs are uniformly referred to as departments, sub-units of countries are referred to as regions.
Limitations
The assessments included in this report took place over a period of eight years. The already comprehensive data collection tool developed by WHO was completed and updated during this time, introducing some variation in the indicators investigated.
The main aim of the visits, and the design of the tool itself, were geared towards identifying priorities for strengthening regulatory capacity. They were not primarily intended to provide comparable indicators of regulatory capacity over time. Not all questions were therefore answered in equal detail for all the countries.
The strengths and weaknesses identifi ed by the authors of the country reports, on which this report is mainly based, refl ect their technical judgement and the views expressed by the regulatory offi cials interviewed.
The evaluation visits were relatively short. Nonetheless, it is thought that the assessors identifi ed the most important issues affecting medicines regulation in each country.
This report presents the situation at the time of the visits. With a few exceptions clearly marked as such, subsequent changes are not refl ected.
1 Source of classifi cation into subregions: Population Division
of the Department of Economic and Social Affairs of the United
Nations Secretariat (2009), World Population Prospects:
The 2008 Revision, http://esa.un.org/unpp.
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Results3.
Country profiles3.1
The 26 countries included in this report constituted 88% of the population of sub-Saharan Africa in 2007. Some key economic and health-related data are summarized below, together with corresponding data for OECD countries around the world. Details are shown in Annex 1.
ECONOMIC INDICATORS
Indicator 26 African countries
OECD countries2
Per capita Gross Domestic Product at average exchange rate (US-$, 2006) *
115 (Burundi) – 7 800 (Gabon)Median: 611
7 333 (Turkey) – 89 123 (Luxembourg)Median: 36 714
Per capita total expenditure on health at average exchange rate (US-$, 2006)
7 (Ethiopia) – 425 (South Africa) Median: 32
352 (Turkey) - 6 719 (USA)Median: 3 317
External resources for health as % of total health expenditure (2006)
1 (South Africa) - 60.3 (Mozambique)Median: 22
0
Out-of-pocket expenditure for health, as % of total health expenditure (2006)**
6 (Botswana) -75 (Cameroon)Median: 39
6 (Netherlands) – 52 (Mexico)Median: 17
* Calculated as: Per capita total expenditure on health at average
exchange rate (US$) / Total expenditure on health as proportion of
gross domestic product. Not shown in Annex 1.
** Calculated as: Private expenditure on health as proportion of total
expenditure on health × Out-of-Pocket expenditure as proportion of
private expenditure on health.
Source: WHO World Health Statistics 2009 [6]
In African countries:
Limited resources were refl ected in very low per •
capita expenditures on health (median: 32 US-$ per inhabitant per year);
Donor dependence was high (median: 22% of health •
expenditure); and
Out-of-pocket expenditure by patients was high •
(up to 75% of health expenditure; median: 39%). A large part of out-of-pocket expenditure for health is generally used for medicines [7].
2 Australia, Austria, Belgium, Canada, Czech Republic, Denmark,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Japan, Korea, Luxembourg, Mexico, the Netherlands, New Zea-
land, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden,
Switzerland, Turkey, United Kingdom, United States.
HEALTH INDICATORS
Indicator 26 African countries
OECD countries
Life expectancy
(years)
46 (Chad, Zambia) –59 (Gabon, Senegal)Median: 52
73 (Hungary, Turkey) –83 (Japan)Median: 80
Neonatal mortality rate (per 1000 live births, 2004)*
17 (South Africa) – 64 (C. Ivoire) Median: 41
1 (Iceland, Japan) – 16 (Turkey)Median: 3
Prevalence of tuberculosis (per 100 000 population, 2007)*
135 (Benin) – 1 104 (Djibouti)Median: 447
3 (Iceland, USA) – 126 (Korea)Median: 9
Prevalence of HIV among adults aged ≥ 15 years (per 100 000 population)*
757 (Niger) – 22 757 (Botswana)
Median: 2 878
9 (Japan) –452 (USA)Median: 125
Percent of years of life lost due to communicable diseases (2004)*
57 (Sudan) –87 (Malawi)Median: 81
3 (Hungary) –26 (Turkey)Median: 5
* Not shown in Annex 1
Source: WHO World Health Statistics 2009 [6]
African countries had a high burden of illness and •
death due to infectious and communicable diseases. Safe, effi cacious, good quality medicines exist to treat these diseases, but health benefi ts will be achieved only if good quality products are made available and used appropriately.
PHARMACEUTICAL SECTOR
IndicatorIndicator 26 African countries (data from country 26 African countries (data from country reports)reports)
Manufacturers Manufacturers > 20 in fi ve countries: Ghana, Kenya, > 20 in fi ve countries: Ghana, Kenya, Nigeria, South AfricaNigeria, South Africa
Distributors Distributors 9 (Djibouti) – 296 (Sudan), private and 9 (Djibouti) – 296 (Sudan), private and public sectorpublic sector
Retail Retail pharmacies pharmacies
9, also acting as distributors (Djibouti) - 9, also acting as distributors (Djibouti) - 1600 registered pharmacies and many other 1600 registered pharmacies and many other outlets (Nigeria), outlets (Nigeria), 1186 pharmacies and 9814 other licensed 1186 pharmacies and 9814 other licensed outlets (Ghana)outlets (Ghana)
The pharmaceutical sector data included in country reports indicated that African countries generally had:
Limited pharmaceutical production capacity, most •
depended mainly on imports.
Some pharmaceutical manufacturing activity catering •
mainly for the domestic and regional demand; however there were some exporting countries; and
A diverse distribution chain, with some types of •
unauthorized outlets suggesting the presence of an informal market (see Annex 1).
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The situation in African countries
Most of the African countries included in this report have very limited health budgets, and limited resources for medicines regulation. There are indications of the presence of parallel, unregulated medicines markets, posing serious risks for individual and public health.
Nevertheless, differences exist in the effi ciency of the regulatory measures implemented by countries, illustrating the impact of political commitment and resources allocated to medicines regulation.
In all countries, the challenge remains to maintain comprehensive, effective regulatory systems in a context of rapidly evolving pharmaceutical technologies and an increasingly globalized market.
Regulatory framework3.2
Legislation
Written laws, Acts or Statutes enacted by Parliament give the NMRA the power to control medicines. Regulations prepared under the authority of an Act (the “Enabling Act”) 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 should cover all products for which medicinal claims are made, as well as related manufacture and trade activities, in the public and private sectors. Countries should update their medicines legislation and regulations regularly to refl ect national realities and to address new pharmaceutical issues as they arise [1].
KEY FINDINGS (SEE ANNEX 2 FOR DETAILS)
In most countries, legislation had evolved over many + years. The enabling act for medicines regulation was enacted later than 2000 in only three countries.
In many countries, the way in which the legal and − explanatory texts were drafted affected the effi ciency of medicines regulation. Successive regulations and decrees created a complex legal framework with overlaps and grey areas.
Regulations for specifi c regulatory functions were − missing in some countries, especially where a transformation process of the NMRA was taking place.
Regulatory scope
In the last few decades, expansion of the regulatory scope has been considered in many countries [8]. A medicine has been defi ned as “Any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefi t of the recipient” [9]. In addition to conventional medicines for human use, this defi nition also includes biological medicines (including vaccines and blood products), veterinary medicines, and traditional and herbal medicines, although the latter category is challenging to defi ne and to regulate [10].
All types of medicines should be regulated by the NMRA. At the same time, implementation of medicines regulation should not be compromised by other, non-regulatory activities performed by the NMRA. [8]
KEY FINDINGS (SEE ANNEX 2 FOR DETAILS)
Seventeen of 26 NMRAs (65%) had the mandate + to control veterinary medicines. In four countries veterinary medicines were controlled by another Ministry, such as the Ministry of Agriculture or Livestock.
Eighteen of 26 NMRAs (69%) had some policy + or provisions to deal with traditional or herbal medicines, eleven of these registered traditional or herbal medicines, another two3 were about to start doing so.
NMRAs in eleven countries− 4 (42%) regulated a wide scope of products, which included foods, poisons, pesticides, bottled water, cosmetics and/or animal food supplements.
In seven countries− 5, the NMRA was involved in designing and implementing national medicines strategies, implementing legislation or coordinating public sector medicines supply; in one case a clearly distinguished unit was in charge of policy issues.
Organizational forms
The choice of a specifi c organizational form will have an impact on the autonomy, visibility and accountability of an NMRA. These factors can in turn affect the organization’s effi ciency in medicines control.
3 Country 02, Country 16 (no regulations yet)
4 Countries 02, 03, 04, 11, 12, 14, 16, 19, 23, 24, 26
5 Countries 01, 09, 13, 17, 18, 22, 23; in Country 15 policy
activities and regulatory functions were carried out by different
organizational units of the NMRA
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10 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s1
One central authority should be accountable for the overall effectiveness of medicines regulation. It should have the legal power from government to acquire and use resources, recruit and dismiss staff, and make independent decisions.
KEY FINDINGS (SEE FIGURE 2AND ANNEX 2 FOR DETAILS)
Historically, most NMRAs in Africa started out as departments under the Ministry of Health. Organizations of this type have little autonomy. They cannot recruit their own staff, nor can they offer adequate salaries to attract and retain qualifi ed experts. With the maturation of regulatory systems, some countries are moving away from this model, and are establishing their NMRAs as autonomous bodies or as centralized parastatal agencies with their own management structures.
Seventeen of 26 authorities (65%) were departments •
of the Ministry of Health, with very little or no autonomy to manage their own funds and human resources.
Seven NMRAs (27%, • including four departments of MoH and two autonomous bodies) were in transition or not formally constituted at the time of the visit.
FIGURE 2: LEGAL FORMS OF NMRAS AT TIME OF VISIT
Department of MoH
Autonomous body
Parastatal agency
4
5
17
Regulatory functions
The responsibilities assumed by the authority should cover all medicines regulatory functions and should be performed in a balanced fashion.
If functions are distributed between different authorities, either horizontally (e.g. ministry of health, ministry of agriculture) or vertically (federal, state/regional and local governments), a central coordinating body should be accountable for all aspects of medicines regulation in the country [1].
KEY FINDINGS (SEE FIGURES 3A AND 3B, AND ANNEX 2 FOR DETAILS)
Four of the 26 NMRAs (15%) had all fi ve main + functions shown in Figure 3B (marketing authorization, licensing, inspection, quality control and pharmacovigilance) under their umbrella.
Seventeen NMRAs (65%) had access to a functional + national regulatory QC laboratory, seven of these laboratories were part of the NMRA. In one of the remaining countries, there was an NMRA lab which had ceased to function several years earlier.
Most countries had fragmented regulatory systems. − Gaps and overlaps of responsibilities were common, especially in licensing (involving the Ministry of Public Health or Ministry of Trade) and inspection (involving Pharmaceutical Councils, regional authorities or public health inspectorates).
Decentralization and cooperation between authorities − was problematic; 12 reports highlighted the lack of communication at operational level.
In many cases, regulatory functions were not − operational and in some cases not even delegated by law to the national medicines regulatory authority.
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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FIGURE 3B: COMBINATIONS OF FUNCTIONS WHOLLY OR PARTLY UNDER THE UMBRELLA OF NMRAS
Number of main functions per for med by NMRA*
Marketing authori zation
Licensing Inspection Quality control
Pharmaco-vigilance
Number of NMRAs
5 / 5 4
4 / 5 9
3
1
3 / 5 1
3
1
2 / 5 1
1
1 / 5 1
0 / 5 (NMRA not yet established) 1
Total 26
* Including functions performed jointly with one or more other authorities
Num
ber
of N
MRA
s
Done by NMRA
Done by other body
Not assigned
Done by NMRA+other
Assigned to NMRA but not done
25
20
15
10
5
0
Mar
ketin
g
auth
oriz.
Licen
sing
Insp
ectio
n
Quality
contro
l
Pharm
aco-
vigila
nce
Control o
f
prom
otion
Control o
f
clin. t
rials
FIGURE 3A: PERFORMANCE OF REGULATORY FUNCTIONS
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12 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s1
Structure and management3.3
Funding
Sustainable funding for NMRAs should be derived from various sources:
1. Fees, which should contribute signifi cantly to operational costs but should not discourage applications,
2. Public funding, to make NMRAs less dependent of the parties which they are mandated to regulate, and
3. Donations to supplement limited public funds.
NMRAs should have the autonomy to retain the fees collected for services provided, and to use them for their own purpose.
KEY FINDINGS (SEE ANNEX 3 FOR DETAILS)
Most NMRAs derived their funding from more than + one source, although the proportions varied from one country to another.
Fees were commonly charged for initial marketing + authorization, renewal and retention. More rarely, fees were charged for importation of medicines, inspection, analysis of samples and registering persons and premises.
Generally, the fees were lower than the cost of services − rendered, and were not retained or redistributed in full.
At the time of the visits, nine NMRAs depended on − government funding, with all fees paid directly to the treasury and not redistributed. Four of these also received donor funding. Funds allocated to the NMRAs by the respective States were not always released on time.
None of the NMRAs assessed had adequate and − sustained funding for its operations.
Human resource management
Personnel engaged in medicines regulation should be individuals of integrity and appropriately trained and qualifi ed. Human resources development programmes should be made available to enable staff to keep up with developments in pharmaceutical science and technology [8].
KEY FINDINGS (SEE ANNEX 3 FOR DETAILS)
In general, human resource management was either non-existent or, where it existed, ineffi cient. This was the case especially where the NMRA was at a low level of hierarchy within the Ministry of Health. As a result, lack of qualifi ed staff affected critical regulatory functions (see Sections 3.4, Marketing authorization, and 3.7, Inspections). Specifi c shortcomings included the following:
Only two of the 26 NMRAs (8%) had a human resource − development plan, which was however not specifi c to the tasks of the NMRA. Specifi c training needs and diffi cult access to sources of current information were noted in most countries.
Job descriptions for key personnel were described as − absent in fi ve countries, and as unclear or outdated in four. Four reports mentioned the absence of an organigram.
In some authorities, responsibilities were not assigned − appropriately. One NMRA director was at the same time the director of the national laboratory, resulting in an unmanageable workload. Three others6 were simultaneously in charge of public sector medicines supply or tenders, creating apotential confl ict of interest.
Five reports− 7 mentioned the absence of a legal advisor on the NMRA’s payroll.
Quality management system
NMRAs perform critical and sensitive functions such handling and assessing marketing application dossiers containing confi dential information, inspecting facilities and handling site master fi les.
A quality management system (QMS) should ensure that the operations of an NMRA are carried out to defi ned, uniform standards, and that each step of the regulatory processes is identifi ed and documented.
6 Countries 13, 20 and 21
7 Countries 02, 12, 17, 18 and 23
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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FIGURE 4: PRESENCE OF QUALITY MANAGEMENT SYSTEMS (QMS) AT NMRAS
NMRA not established
Not described in report
No QMS
Being drafted
Partially implemented
2
6
4
12
2
(see Annex 3 for details)
KEY FINDINGS (SEE FIGURE 4 ANDANNEX 3 FOR DETAILS)
Four NMRAs (15%) were in the process of + implementing a QMS and had elements of the system in place, two others were drafting a system.
None of the NMRAs had implemented a comprehensive − QMS.
IMPARTIALITY AND TRANSPARENCY
Medicines regulation is a public policy that restricts private sector activities in order to attain social goals – the promotion of public health - set by the State. Confl icting interests therefore need to be recognized and managed appropriately.
To provide credible regulatory services, NMRAs must have specifi c measures in place to avoid confl ict of interest in decision-making, to ensure confi dentiality, to make their rules and decisions transparent, and to consult with stakeholders.
KEY FINDINGS (SEE ANNEX 3 FOR DETAILS)
Nine of the 26 NMRAs had set up websites at the time + of the visits. Five of these were in need of updating, one had links which were not functioning correctly. As at November 2009, fi ve additional sites were identifi ed, one of the initial nine could no longer be found [11].
Consultation with stakeholders took place in most + countries, although it tended to be limited to specifi c issues (e.g. regulations) or groups (e.g. professional associations).
Current information was not always publicly available: − lists of approved products or establishments were often missing and/or outdated. Little information was made public on decision-making.
Twenty-three− 8 of 26 NMRAs (88%) had no written declarations of interest and confi dentiality agreements in place, although some had general rules of conduct such as a code for civil servants. In the three countries which did have a specifi c written system, this did not apply to all technical staff involved in regulatory functions.
Medicines registration 3.4 (marketing authorization)
Authorization of medicines for sale in a country, based on a scientifi c assessment of their safety, effi cacy and quality, could be considered as the core regulatory function.
To assess applications for marketing authorization, NMRAs need the following:
1. Legal basis, giving the NMRA the power to grant, renew, vary, suspend and withdraw of marketing authorization
2. Guidelines for applicants, setting out the conditions, content and format of applications, AND the detailed technical requirements against which dossiers will be assessed, based on international guidelines [e.g. 12, 13, 14]
3. Standardized operating procedures to assess the submissions, and standard formats to communicate and publish the outcomes
4. Expert assessors in adequate numbers and with specifi c, current expertise
5. Logistics for management, secure storage, retrieval and exchange of data with other regulatory departments, as well access to current scientifi c and technical information
6. Mechanisms to consider other, stringent NMRAs’ decisions
KEY FINDINGS (SEE FIGURE 5 AND ANNEX 4 FOR DETAILS)
Some evaluation of technical documents was + performed in 19 of 26 countries (73%) to varying degrees of stringency at least for generic medicines.
Although the aim of the visits was to identify critical − gaps (not to document the consistency of the technical
8 All except Countries 11, 15 and 26
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14 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s1
evaluation process with WHO guidance), it can be concluded that the technical standard of evaluations was generally not in line with WHO standards. The reports from four countries9 mentioned that guidelines did not require proof of bioequivalence for generics. At least three NMRAs10 did not require the manufacturer to have GMP certifi cation. At least six NMRAs11 did not assess summaries of product characteristics (SPC).
The capacity to assess applications for new innovator − products was almost non-existent in most countries; one country relied exclusively on well-qualifi ed external assessors, but organizational issues caused delays in assessments.
NMRAs in seven countries conducted either only an − administrative review of documents or no review at all at the time of the visit.
FIGURE 5: PROCESSES IN PLACE FOR GRANTING MARKETING AUTHORIZATION FOR MEDICINES
System not yet established
No process ongoing at time of visit
MA granted without evaluation
Administrative review of documents
Evaluation of technical documents
Process for granting MA
Num
ber
of N
MRA
s
25
20
15
10
5
0
1. Legal basis and regulations
Eighteen of 26 NMRAs (69%) operated on a legal + basis which empowered them to assess applications for marketing authorization, with regulations that briefl y outlined the requirements or listed the components of dossiers to be submitted for different types of products.
Provisions for renewal of marketing authorizations + were in place, usually after 5 years.
Seven countries had provisions which exempted wide − ranges of products (such as public sector imports
9 Countries 05, 09, 20 and 25
10 The reports state that GMP was verifi ed in Countries 02, 11 and
05 (in the latter country the system was not yet functional); and
that it was not required in Countries 04, 16 and 18.
11 Seven reports stated that SPC were not being assessed (countries
02, 03, 04, 13, 14, 22 and 24). Where SPC were assessed, they
were not necessarily published as part of marketing authoriza-
tion (see also Annex 4).
or donations) from registration or from specifi c requirements irrespective of quality risk. For example, in one country, all oral solid-dose anti-infectives were exempt from in vivo bioequivalence studies, regardless of their biopharmaceutical classifi cation.
2. 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. Some countries had guidelines which described the required content of submissions and gave brief instructions, but did not give suffi cient guidance on technical issues such as bioequivalence and stability. Others described only the administrative steps, yet others provided only checklists. A specifi c format for submissions was not required in any of the countries.
Only three NMRAs (12%) provided detailed technical − guidelines, although this did not necessarily mean that they were in line with all applicable WHO guidance.
3. Procedures for assessment
Written standard operating procedures for dossier assessment were either absent altogether, or they described only administrative steps such as checking the completeness of dossiers, payment of fees or inclusion of samples, or they were checklists of the elements of the assessment methodology.
Adequate SOPs for dossier assessment were in place − in only three countries.
Timeframes for assessment of applications ranged from 3 months to 5 years, depending on the complexity of assessments and available resources. Fast-track mechanisms existed for certain needed product types.
Although overall assessment time frames were long, − little time was available for a thorough in-depth assessment by experts due to scheduling diffi culties and backlogs.
4. Expert assessors
Most NMRAs had formal advisory committees. However, not all committees were operational, bringing assessment to a halt in two countries. Eleven countries used external experts, two of them exclusively. Appointment of committee members and experts was not necessarily based on specifi c regulatory expertise, and provisions for confi dentiality and declaration of interest were lacking in most countries (see also Annex 3). Two
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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reports12 mentioned the short preparation and meeting times available for committee members to make their decisions, meaning that they may not be able to read all documents and carry out any real assessment.
Twenty-four of 26 country reports (92%) mentioned − the shortage of adequately qualifi ed assessors as an obstacle to timely dossier evaluation.
5. Logistics
Only four NMRAs (15%) had appropriate archiving − space to store confi dential data securely.
Only six of 26 countries (23%) had coherent, − networked computerized systems designed for medicines registration in place. Nine (35%) had only manual systems.
The latter shortcoming affected transparency and information-sharing with other departments. Lists of registered products were not readily available, which made it diffi cult to verify the registration status of medicines circulating in the market and those being imported. The countries which did publish a list did not include the approved summaries of product characteristics (SPC), needed to verify package inserts, information for health professionals and advertising claims.
12 Countries 03 and 26
6. Recognition of other NMRA's decisions
Certifi cates of pharmaceutical products (CPPs) issued under the provisions of WHO Certifi cation Scheme on the quality of pharmaceutical products moving in international commerce [15] were commonly requested as part of applications, but usually without considering the capacity of the issuing regulatory authority to certify that the data on the certifi cates were correct. Conversely, one report from an exporting country13 mentioned that the NMRA “issues CPP without ascertaining that all prerequisites as specifi ed by WHO are fulfi lled”.
Only two NMRAs (8%) explicitly relied on other − regulatory bodies/organizations which they considered stringent, including the WHO Prequalifi cation Programme [16] in one case.
The lack of mechanisms and procedures that would enable NMRAs to benefi t from the scientifi c assessments and inspections carried out by other well resourced and established regulators is a major cause of concern, as most of the authorities in the region have limited human resources and scientifi c expertise.
13 Country 24
Num
ber
of N
MRA
s
25
20
15
10
5
0
Adequate Existing but inadequate Not existing Not mentioned in country report
Guidelines
(tech. detail) SOPs for
assessment Assessors
Legal basis
(outline)Secure filin
g
space IT system
FIGURE 6: RESOURCES FOR MEDICINES REGISTRATION
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16 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s1
Licensing of activities3.5
Licensing of pharmaceutical establishments
As can be seen from the country profi les, health budgets in African countries are low, high percentages of health costs are paid out of pocket, and there are many types of medicines outlets not managed by a pharmacist. Concerns about the parallel medicines market were voiced in most reports, such as this typical statement14: “The illicit medicines market has become a real plague in [the country]. All therapeutic classes can be found, including psychotropic medicines, and there is no national strategy to combat this situation”.
A mandatory system of licensing manufacturers, wholesalers/distributors and retailers is essential to ensure that medicines conform to acceptable standards of quality, safety and effi cacy until they reach the end user. Licensing must be complemented by inspections (see Section 3.7) and market surveillance (see Section 3.9) to monitor and enforce compliance.
NMRAs should ensure that all premises and practices used to manufacture, store, distribute and dispense pharmaceutical products comply with current guidelines on Good Manufacturing Practice [17], Good Storage Practice [18] Good Distribution Practice [19] and Good Pharmacy Practice (GPP) [20].
KEY FINDINGS (SEE ANNEX 5)
All countries except one had systems in place to + license pharmaceutical establishments.
GMP was not required in at least 9 countries− 15. In at least two countries where GMP was required16, none of the established manufacturers had GMP certifi cation.
Only fi ve of 26 countries (20% - see Annex 7) had − published GMP guidelines meeting WHO standards (two had national texts, and another three used the WHO text). Only one country (4%) had adequate GDP guidelines.
Authorities other than the NMRA were involved in − licensing in 16 countries (62%), resulting in overlaps, grey areas and gaps in the control of pharmaceutical activities.
14 Country 17
15 Countries 03, 06, 08, 09, 12, 14, 17, 24 and 25
16 Countries 02 and 05
Decentralization of licensing, involving regional − authorities, was not organized effi ciently. Lack of coordination between departments and with enforcement agencies was commonly highlighted.
Licences or renewals were granted without inspection − in some instances.
In practice the requirements for Good Manufacturing − Practice, Good Distribution Practice and Good Pharmacy Practice were poorly enforced. For example, In one country17 only a single one of many established manufacturers was licensed.
Import and export control3.6
A system to grant marketing authorization for pharmaceutical products is not in itself a suffi cient mechanism to control the quality of products circulating in the country. It should be complemented by a range of other control measures (see also Figure 1), including the authorization of each import act of pharmaceutical products.
Each act of importation should be subject to authorization by the NMRA on the basis of the product’s registration (marketing authorization) status.
Products for export should be subject to the same standards as those for domestic consumption.
KEY FINDINGS (SEE ANNEX 6 FOR DETAILS)
Control of imported products was weak. In at least − eight countries18 (31%) there was no effi cient system to verify the marketing authorization status and exemptions for imported products.
Cooperation with police and customs was consistently − described as problematic.
Mechanisms to control exported medicines were − either absent or not stringently enforced. One report19 mentioned manufacturers’ illegal practice of issuing “free sale certifi cates”, which leaves all control to the receiving country.
17 Country 04
18 Countries 07, 09, 13, 18, 22, 23, 24 and 25
19 Country 02
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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Inspections 3.7
Inspection of pharmaceutical facilities should enable medicines regulatory authorities to monitor whether pharmaceutical activities are carried out in accordance with approved standards and guidelines. The effi ciency of inspections has a direct impact on the extent to which medicines control is enforced.
A legal basis must be in place for inspections and enforcement of compliance with relevant good practices. Routine inspections should be planned and implemented to verify this compliance regularly.
A quality management system [21] should ensure that inspections are planned, conducted, documented and followed up in a consistent way, based on risk assessment.
Enough qualifi ed inspectors and suffi cient logistic resources must be available to cover the geographic area to be regulated.
KEY FINDINGS (SEE FIGURE 7 ANDANNEX 7 FOR DETAILS)
A legal basis empowering the relevant authority to + perform inspections was in place in 17 countries.
SOPs for inspection, if any, were mostly in checklist − format and were not comprehensive.
No NMRA had a comprehensive quality management − and planning system for inspections in place.
Shortages of qualifi ed inspectors were a universal − problem. The need for specifi c training of inspectors in current GMP was commonly highlighted.
Potential confl icts of interest were noted in at least − three countries20.
Inadequate logistic resources, especially means − of transport and communication, were a major constraint.
The effectiveness of inspections suffered from these constraints.
20 In Countries 02 and 05 the inspectors were also permitted to
be supervisors/technical directors of pharmacies. In Country 03
pharmacists from distribution channels and manufacturers were
used as inspectors
Num
ber
of N
MRA
s
25
20
15
10
5
0
Adequate Existing but inadequate Not existing No information or not applicable
Legal basis
Published
GMP textSOPs
QMS
InspectorsLogistic
s
FIGURE 7: RESOURCES FOR INSPECTIONS
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18 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s1
Quality control3.8
Quality control (QC) aims to verify that products comply with the specifi cations of the marketing authorization. Even if pre-marketing samples meet defi ned standards, the same quality standards may not be met by each batch of product put on the market. QC testing of post-marketing samples thus acts as a deterrent against negligent or fraudulent manufacturing and trading practices [8].
NMRAs should have access to a quality control laboratory with adequate capacity to undertake quality surveillance.
QC facilities must have enough qualifi ed personnel and the necessary equipment and materials, and must operate according to established standards [8]. A Quality Management System (QMS), such as ISO 17025 [22], provides a framework for QC laboratories to operate according to defi ned procedures and standards. WHO’s guidance on Good Laboratory Practice [23, 24] provides detailed advice on organizational and technical issues.
If dossiers are assessed and samples tested, good collaboration between assessors and laboratory staff needs to be in place.
KEY FINDINGS (SEE ANNEX 8 FOR DETAILS)
A QMS was in place at fi ve (29%) of the 17 functioning + regulatory laboratories; three others had partial systems which were lacking essential elements and were not fully operational.
Satisfactory staffi ng and equipment were in place + in the majority of cases, but six laboratories were housed in inadequate buildings.
Ten reports mentioned QC testing for pre-marketing applications. However, the laboratories were not always given the relevant dossiers, manufacturer’s reference materials and validated methods.
Market surveillance 3.9 (product quality monitoring, pharmacovigilance, control of promotion and advertising)
Product quality monitoring
Substandard pharmaceuticals may circulate in the market if good practices in manufacturing, distribution and storage are not adhered to.
In addition, counterfeiting – the production and distribution of medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source - is becoming an increasing problem. It requires a coordinated response from different sectors both at country level and internationally [25].
In both cases, the defi cient products pose a risk for individual and public health.
A risk-based system of inspections and sampling should be in place to monitor the quality of pharmaceutical products on the market. Manufacturers should be obliged to report complaints and quality problems to the NMRA. An effective recall procedure should be in place to remove defective products from the market.
The NMRA should coordinate an anti-counterfeiting programme with all concerned parties, including industry, customs, police and any other stakeholders involved in trade or distribution of pharmaceuticals.
FIGURE 8: QUALITY CONTROL TESTING
Num
ber
of N
MRA
s
25
20
15
10
5
0
Yes Partial None No information No functioning regulatory laboratory
Adequate
equipmentQC Lab
has QMS Adequate
staff
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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KEY FINDINGS (SEE ANNEX 9 FOR DETAILS)
Fourteen of 26 NMRAs (54%) lacked a quality − monitoring programme altogether; 7 tested samples in case of complaints or in the framework of specifi c programmes, and only 5 (19%) had a systematic approach.
Twenty of 26 NMRAs (77%) lacked a written procedure to − organize an effective recall, of the existing six procedures three needed clarifi cation. Five reports21 noted the lack of batch traceability needed to recall products. This fi nding is consistent with the general absence of published GDP guidelines mentioned in Section 4.5.
Anti-counterfeiting measures included inspections − and surveillance in fi ve countries and awareness programmes in three. No country had a specifi c, comprehensive programme in place at the time of the visits.
Pharmacovigilance (monitoring of adverse reactions to medicines)
Pre-marketing clinical trials are usually conducted on a small numbers of volunteers, who may not always be representative of the target population for whom the medicine is intended. Not all adverse reactions can be anticipated from these studies.
NMRAs should implement a system to monitor adverse events. For this to be effective, there must be a high probability for adverse events to be identifi ed and reported, reports must be reviewed and validated by experts, results must be fed back, and appropriate regulatory action must be taken [8].
21 Countries 09, 14, 18, 20; Country 25 (no traceability of free
samples distributed to patients and doctors)
KEY FINDINGS (SEE ANNEX 9 FOR DETAILS)
Eight of 26 countries collected reports on adverse + events, with three of the programmes being suffi ciently established to contribute a sizeable number of results. Seven of the 8 countries were members of the WHO Programme for International Drug Monitoring(see http://www.who-umc.org/).
Where it existed, pharmacovigilance was generally + not well integrated with other regulatory activities or with clinical surveillance measures implemented by specifi c national or NGO treatment programmes.
Control of medicine promotion and advertising, provision of drug information
Information propagated through promotion and advertising can signifi cantly infl uence the way in which medicines are prescribed by health professionals and used by consumers. Inaccurate and misleading information therefore poses a health risk [8].
NMRAs should control promotion and advertising to ensure that any claims made correspond to the approved summary of product characteristics (SPC). They should also provide independent information on medicines to the public and health professionals [1].
KEY FINDINGS (SEE ANNEX 9 FOR DETAILS)
Most countries had some legal provisions for the + control of medicines promotion. Seven of 26 countries (27%) controlled pharmaceutical promotion to varying extents.
In 19 countries (73%) there was no control of − promotion and advertising in practice, meaning that even if the regulations were in place, they were not implemented.
At least 13 NMRAs did not provide any independent − medicines information to the public.
FIGURE 9: MARKET CONTROL MECHANISMS
Num
ber
of N
MRA
s
25
20
15
10
5
0
Yes Exists, inadequate No No information
Quality
monitoring Anti-c'feiting
programme Recall
procedure Pharmaco-
vigilance Control of
promotion
p1980851_Flash-OMS-EMPP.indd 1980851_Flash-OMS-EMPP.indd 19 11/12/10 8:32:11 PM11/12/10 8:32:11 PM
20 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
Oversight of clinical trials3.10
Clinical trials are an essential component of pharmaceutical research and development. They serve to establish the safety and effi cacy of new medicines, and to develop new treatment uses of well known medicines. Clinical trials also include in vivo bioequivalence studies carried out with generic medicines to establish their therapeutic interchangeability with originator products. In all these types of studies the ethical rights and the safety of trial subjects must be protected, and the methodology must be designed in such a way as to arrive at useful, scientifi cally valid results.
NMRAs should control clinical trials jointly with external bodies such as national or institutional ethics committees.
Trials should conform with ethical principles for medical research involving human subjects (the Declaration of Helsinki [26]). Guidelines by the Council of International Organization of Medical Sciences (CIOMS)22 provide valuable additional information on research ethics.
WHO guidelines for GCP [27] and GLP [23] should be followed. GMP of investigational products should be verifi ed. Other more specifi c guidelines on clinical research may apply.
Trials should be monitored for compliance with all applicable guidelines. Investigators should be required to report on the outcomes promptly, including any serious adverse events encountered.
22 www.cioms.ch
KEY FINDINGS (SEE FIGURE 10AND ANNEX 10 FOR DETAILS)
In 18 of 26 countries (69%) clinical trials were + controlled to some extent, mostly with regard to ethical aspects.
Where ethics committees were involved, NMRAs − retained little or no control due to lack of capacity, unclear assignment of responsibilities or non-representation in the relevant committees.
Adherence to GLP and GCP was not a requirement − in 22 countries (85%); detailed GCP guidelines were found in only two countries (8%).
Eight reports mentioned the absence of import − controls and GMP requirements for investigational products.
Only four country reports mentioned that inspections − of clinical trials were being conducted.
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p20 80851_Flash-OMS-EMPP.indd 2080851_Flash-OMS-EMPP.indd 20 11/12/10 8:32:14 PM11/12/10 8:32:14 PM
21 As se s s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
Conclusions4.
The countries included in this report had legal provisions for most essential aspects of medicines control. However, their regulatory systems presented some critical weaknesses. The legal framework had evolved over time, resulting in a fragmentation of responsibilities with gaps and grey areas, and a multitude of provisions which were diffi cult to implement. Many NMRAs had little power and autonomy, and oversaw a limited range of regulatory functions with little accountability or managerial commitment. In almost all countries visited, lack of sustainable funding restricted the regulatory operations. Virtually all NMRAs suffered from staff shortages. For the most part, assessors and inspectors were not at the level of current scientifi c and technical expertise needed for their regulatory tasks. Regulatory requirements and processes were not in line with recommended WHO standards.
As a result, medicines regulation was not carried out to the full extent required to ensure the quality, effi cacy and safety of medicines in African countries. The fi ndings confi rm the results of a 2004 questionnaire survey conducted by WHO in 38 African member states, which found that 90% of countries did not provide or enforce adequate regulatory functions [28].
Despite the universally scarce resources and the health workforce crisis experienced throughout sub-Saharan Africa [29], the effi ciency of medicines control varied among countries, showing that political commitment at national level can make a difference.
On the positive side, it was noted that many countries were committed to improve their medicines regulatory capacity: Reviews of the systems were invited, and regulatory structures were being adapted. However, in many cases, the transformation processes created new administrative hurdles which complicated effective decision-making, management and release of funding.
The follow-up assessments conducted in four countries showed that progress in specifi c aspects was achievable. However, the improvements were partial, and were not suffi cient to build sound, well-resourced national medicines regulatory systems.
The way forward should be towards effective implementation of medicines control in practice. Political commitment and substantial human and fi nancial resources will be needed for this purpose. Countries will need to take concerted action if they are to expand access to medicines of assured quality for their populations. The following approaches will be useful to build regulatory capacity in Africa:
Encourage and assist WHO Member States to •
regularly assess their own regulatory systems in a standardized way. The WHO assessment tool [4] and the accompanying guidance [5] have been developed for this purpose.
Consider mechanisms to share the outcomes of •
regulatory assessments.
Work towards effective implementation of all •
essential regulatory functions under the umbrella of NMRAs.
Continuously adapt and update the legal framework •
for medicines regulation in accordance with internationally recognized norms, standards and best practices.
Encourage WHO Member States to grant their NMRAs •
an adequate organizational structure, suffi cient autonomy and sustainable resources to enable them to carry out their operations.
Provide specifi c, relevant training for assessors, •
inspectors and other technical staff, in line with current technical recommendations and good practices.
p2180851_Flash-OMS-EMPP.indd 2180851_Flash-OMS-EMPP.indd 21 11/12/10 8:32:22 PM11/12/10 8:32:22 PM
22 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
Ann
exes
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X 1:
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on23
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External resour ces for health as % of total expend. on health (2006)
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Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p22 80851_Flash-OMS-EMPP.indd 2280851_Flash-OMS-EMPP.indd 22 11/12/10 8:32:29 PM11/12/10 8:32:29 PM
23 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
24
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p2380851_Flash-OMS-EMPP.indd 2380851_Flash-OMS-EMPP.indd 23 11/12/10 8:33:33 PM11/12/10 8:33:33 PM
24 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
AN
NE
X 2
: Org
aniz
atio
nal
stru
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d im
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regu
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= N
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noth
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ody,
= tw
o ot
her b
odie
s, =
NM
RA a
nd a
noth
er b
ody,
= N
MRA
and
two
othe
r bod
ies,
= n
ot a
ssig
ned
to a
spe
cifi c
bod
y;
shad
ed: o
pera
tiona
l at t
he ti
me
of th
e vi
sit
Coun
try
Year
of
en-
ablin
g Ac
t
Auth
orit
y an
d le
gal f
orm
:
A:
Gov
ernm
ent
Dep
artm
ent
B:
Aut
onom
ous
body
C:
Par
asta
tal a
genc
y
Mar
keti
ng
auth
oriz
a tio
n (s
ee a
lso
3.4)
Lice
nsin
g &
im
port
con
trol
(s
ee a
lso
3.5)
Insp
ec ti
on (s
ee a
lso
3.7)
Qua
lity
cont
rol
(see
als
o 3.
8)
Phar
mac
o-vi
gila
nce
(see
als
o 3.
9)
Cont
rol o
f pr
omot
ion
(see
als
o 3.
9)
Cont
rol o
f cl
inic
al t
rial
s (s
ee a
lso
3.10
)
Vet
med
sTr
ad./
her-
bal
med
s
EAST 02
1978
Auto
nom
ous
body
,(la
ter
sem
i-au
tono
mou
s ag
ency
) B
Yes
Yes
0319
88Se
mi-
auto
nom
ous
para
stat
al B
oard
C
Min
iste
r on
NM
RA
adv
ice
Yes
No
0419
99
Para
stat
al, a
uton
omou
s bo
dy +
advi
s. bo
ard
(no
tech
nica
l com
mitt
ees)
C
Yes
Yes
0619
99D
epar
tmen
t w
ithi
n M
oH, t
rans
itio
nal
(aw
aiti
ng t
rans
form
atio
n in
to
agen
cy)
A
Yes
No
0719
98D
eleg
ated
to
Phar
m D
ept
MoH
(N
MRA
nev
er f
orm
ally
est
ablis
hed)
A
Oth
er
auth
.N
o
0919
82D
epar
tmen
t w
ithi
n M
oH
(not
offi
cia
lly c
onst
itut
ed)
A
Oth
er
auth
.Ye
s
1020
01D
epar
tmen
t w
ithi
n M
oH(N
MRA
pro
pose
d, n
ot y
et
esta
blis
hed)
A
N
oN
o
1519
63D
epar
tmen
t an
d Se
cret
aria
t in
MoH
on
beh
alf
of a
uton
omou
s Bo
ard
A
Oth
er
auth
.Ye
s re
gist
1620
04Au
tono
mou
s bo
ard
(not
yet
ap
prov
ed a
t ti
me
of v
isit
)B
Ye
sYe
s
2019
57Bo
ard
as b
ody
corp
orat
e (a
ll te
chni
cal s
taff
sec
onde
d by
MoH
)B
Ye
sN
o
26 1
952
Body
cor
pora
te (B
oard
and
Se
cret
aria
t)B
Ye
sYe
s re
gist
SOU
TH
1119
65Ag
ency
, sup
port
ed b
y M
oH(+
prof
essi
onal
cou
ncil)
C
Yes
Yes
2119
92
Med
icin
es re
gula
tory
dep
artm
ent
wit
hin
MoH
(fun
ctio
ns a
nd
resp
onsi
bilit
ies
not
clea
rly s
tate
d in
le
gisl
atio
n)
A
No
No
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p24 80851_Flash-OMS-EMPP.indd 2480851_Flash-OMS-EMPP.indd 24 11/12/10 8:33:40 PM11/12/10 8:33:40 PM
25 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
Coun
try
Year
of
en-
ablin
g Ac
t
Auth
orit
y an
d le
gal f
orm
:
A:
Gov
ernm
ent
Dep
artm
ent
B:
Aut
onom
ous
body
C:
Par
asta
tal a
genc
y
Mar
keti
ng
auth
oriz
a tio
n (s
ee a
lso
3.4)
Lice
nsin
g &
im
port
con
trol
(s
ee a
lso
3.5)
Insp
ec ti
on (s
ee a
lso
3.7)
Qua
lity
cont
rol
(see
als
o 3.
8)
Phar
mac
o-vi
gila
nce
(see
als
o 3.
9)
Cont
rol o
f pr
omot
ion
(see
als
o 3.
9)
Cont
rol o
f cl
inic
al t
rial
s (s
ee a
lso
3.10
)
Vet
med
sTr
ad./
her-
bal
med
s
MID
DLE
0519
92D
epar
tmen
t of
MoH
(p
ropo
sed,
not
yet
impl
emen
ted)
A
Oth
erN
o
0819
90D
epar
tmen
t w
ithi
n M
oHA
N
oYe
s re
gist
1219
3325
19
52,
1982
Dep
artm
ent
wit
hin
MoH
A
Yes
(no
regu
l)
Yes
regi
st
1720
00D
epar
tmen
t w
ithi
n M
oH
A
Ye
sYe
s
2519
61D
epar
tmen
t w
ithi
n M
oHA
Ye
sYe
s re
gist
WES
T
0119
94D
epar
tmen
t w
ithi
n M
oHA
N
oYe
s re
gist
1320
06D
epar
tmen
t w
ithi
n M
oHA
No
No
1419
62,
1994
Dep
artm
ent
wit
hin
MoH
A
Ye
sYe
s
1819
84D
epar
tmen
t w
ithi
n M
oH
A
Ye
sYe
s re
gist
1919
92Bo
ard
unde
r co
ntro
l of
MoH
(+Pr
of. c
ounc
il +S
tand
ards
boa
rd)
C
Ye
sYe
s re
gist
2219
95D
epar
tmen
t w
ithi
n M
inis
try
of P
ublic
H
ealt
hA
Yes
Yes
regi
st
2319
54D
epar
tmen
t w
ithi
n M
oH
A
Ye
sYe
s re
gist
2419
93 P
aras
tata
l age
ncy
(+pr
ofes
sion
al c
ounc
il +e
nfor
cem
ent
agen
cy)
C
Ye
sYe
s re
gist
25
1933 leg
isla
tion
on
th
e pra
ctic
e of
ph
arm
acy
rem
ain
s th
e bas
ic leg
isla
tive
fra
mew
ork
; N
MR
A w
as c
on
stit
ute
d b
y le
gis
lati
on
of
1982.
p2580851_Flash-OMS-EMPP.indd 2580851_Flash-OMS-EMPP.indd 25 11/12/10 8:33:44 PM11/12/10 8:33:44 PM
26 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
AN
NE
X 3
: Org
aniz
atio
nal
stru
ctur
e an
d m
anag
emen
t
Regi
onType26
Fund
ing:
Sou
rces
Re
tain
edAd
equa
te,
sus t
aine
d
Qua
lity
Man
age m
ent
Syst
em
Staf
f (t
echn
ical
+a
dmin
)
Hum
an r
esou
rce
(HR)
m
anag
emen
t
Code
of
cond
uct
/ in
tere
sts
Info
rmat
ion,
co
nsul
tati
on w
ith
stak
ehol
ders
Web
-sit
e27G
aps
/ rem
arks
Coun
try
EAST 02
B Pu
blic
, don
or, f
ees
Yes
No
Bein
g dr
afte
d35
+16
Insu
ffi c
ient
Stru
ctur
e no
t do
cum
ente
d. N
o H
R de
velo
pmen
t pl
anN
oSo
me
repo
rts
(exc
ept
fi nan
cial
)**
Goo
d co
nsul
tati
on/
coop
erat
ion
nati
onal
ly
03C
Publ
ic, f
ees,
com
mis
sion
Yes
No
No
Boar
d: 7
5 co
mm
itte
es
No
HR
dev.
plan
. Gap
s in
jo
b de
scrip
tion
sN
oSo
me,
web
site
nee
ds
upda
ting
Ye
s**
*H
eavy
relia
nce
on
dono
r/pr
ojec
t fi n
ance
04C
Publ
ic, f
ees
to g
ov.,
part
ners
No
No
58 +
55
Insu
ffi c
ient
Plan
ning
, job
de
scrip
tion
s, bu
t no
HR
dev.
pla
nN
ot s
peci
fi cRe
port
s av
aila
ble
thro
ugh
Parli
amen
t**
No
tech
nica
l com
mit
-te
es t
o su
ppor
t Bo
ard
06A
Publ
ic, d
onor
Yes
(pro
pose
d)N
o N
oIn
suffi
cie
ntN
o ow
n re
crui
ting
. Tr
aini
ng p
lan
exis
tsN
o In
fo n
ot p
ublic
ly
avai
labl
e**
Und
erre
sour
ced
tran
s-it
iona
l org
aniz
atio
n
07A
Publ
ic, f
ees
to
gove
rnm
ent,
dono
r N
oN
oN
o7
+3
Insu
ffi c
ient
Job
desc
ripti
ons,
no
own
recr
uiti
ngN
oVe
ry li
ttle
; web
site
of
MoH
not
use
dN
oLo
w s
alar
ies;
in
adeq
uate
bui
ldin
gs
09A
Publ
ic, f
ees
to
gove
rnm
ent
No
No
No
7 te
chni
cal
Insu
ffi c
ient
No
HR
dev
plan
, no
job
desc
ripti
ons
No
Info
rmat
ion
not
gene
rally
sha
red
No
No
auto
nom
y,
inad
equa
te b
uild
ings
10A
Fees
, im
port
le vi
es
(pro
pose
d)Ye
sn/
a(N
MRA
not
es
tabl
ishe
d)2
n/a
n/a
n/a
n/a
(No
regu
lato
ry
auth
orit
y)
15A
Publ
ic, f
ees,
dono
rN
ot y
et
(agr
eed)
No
Not
com
pre-
hens
ive
35 (B
oard
) +S
ecr.
No
own
recr
uitm
ent.
Unc
lear
job
desc
ripti
ons;
som
e tr
aini
ng p
lann
ed
Yes
for
ex-
tern
al, +
oath
-ta
king
Som
e co
nsul
tati
on,
no in
fo o
n de
cisi
ons
Yes
Polic
y ce
ntra
lized
but
re
gula
tory
fun
ctio
ns
dece
ntra
lized
16B
Publ
ic, f
ees
Yes
No
No
(Tra
nsi t
iona
l)
Insu
ffi c
ient
No
stra
t. pl
an; l
ack
of
staf
f to
man
age
fi nan
ceN
oN
o w
ebsi
teN
oCr
itic
al p
osit
ion
of D
ir.
Gen
eral
not
fi lle
d
20B
Fees
onl
yYe
sN
o?
(Not
for
in
spec
tion
s)Te
ch st
aff s
e-co
n d ed
by
MoH
No
own
recr
uitin
g: n
o H
R m
anag
emen
t sys
tem
sN
oO
utda
ted
web
site
, di
ffi c
ult
to a
cces
sYe
sRe
gist
rar
in c
harg
e of
pr
ocur
emen
t
26B
Publ
ic (2
0 Bo
ard
mem
bers
onl
y); f
ees
Yes
No
Not
impl
e-m
ente
d of
fi cia
lly
Secr
etar
iat:
68+
55
Ade
quat
e
Job
desc
ripti
ons
(200
1); t
rain
ing
(not
sy
stem
atic
)
Yes
(not
for
ex te
rnal
)
Web
site
: som
e lin
ks t
o fo
rms
not
wor
king
Yes
Secr
etar
iat
shou
ld b
e gi
ven
resp
onsi
bilit
y fo
r da
ily f
unct
ioni
ng
SOU
TH 11C
Publ
ic, f
ees
to
gove
rnm
ent
No.
Fee
s-on
ly s
yste
m
prop
osed
No
22 m
embe
rs,
110
MoH
14
6 ex
tern
al
No
HR
dev
plan
for
M
oH s
taff
, unc
lear
job
desc
ripti
ons
Yes
for
exte
rnal
, gen
co
de f
or M
oH
Info
rmal
co
nsul
tati
on
Adm
inis
trat
ive
info
av
aila
ble
Yes
No
own
staf
f -
exte
rnal
par
t-ti
me
expe
rts
and
MoH
sta
ff
21A
Publ
ic, f
ees
to
gove
rnm
ent
No
No
No
6 +z
ero
Insu
ffi c
ient
Inad
equa
te. N
o ow
n re
crui
ting
. Hig
h tu
rnov
erN
oM
oH w
ebsi
te, g
uide
-lin
es n
ot p
oste
dYe
sLa
ck o
f st
aff
and
fund
ing
a m
ajor
pr
oble
m
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p26 80851_Flash-OMS-EMPP.indd 2680851_Flash-OMS-EMPP.indd 26 11/12/10 8:33:50 PM11/12/10 8:33:50 PM
27 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
turn
over
prob
lem
Regi
on
Type26
Fund
ing:
Sou
rces
Re
tain
edAd
equa
te,
sus t
aine
d
Qua
lity
Man
age m
ent
Syst
em
Staf
f (t
echn
ical
+a
dmin
)
Hum
an r
esou
rce
(HR)
m
anag
emen
t
Code
of
cond
uct
/ in
tere
sts
Info
rmat
ion,
co
nsul
tati
on w
ith
stak
ehol
ders
Web
-sit
e27G
aps
/ rem
arks
Coun
try
MID
DLE
05A
Publ
ic, d
onor
, fee
s pr
opos
edN
oN
o(N
MRA
not
es
tabl
ishe
d)
14 +
16
Insu
ffi c
ient
No
HR
deve
lopm
ent
plan
No
(gen
eral
on
ly)
Litt
le in
form
atio
n-sh
arin
gN
oSt
ruct
ure
not
yet
func
tion
al
08A
Publ
ic, f
ees
to
gove
rnm
ent
Redi
strib
u-ti
on 4
5%N
o22
tec
hnic
al
Nee
d tr
aini
ng
No
HR
deve
lopm
ent
plan
No
NM
RA n
ot u
sing
M
in. P
ublic
Hea
lth
web
site
N
oG
over
nmen
t fu
ndin
g no
t al
way
s re
leas
ed
12A
Publ
ic; f
ees,
dona
tion
sRe
dist
ribu-
tion
25%
No
No
7 te
chni
cal
Insu
ffi c
ient
No
HR
deve
lopm
ent
plan
. No
lega
l sup
port
No
Cons
ulta
tion
on
new
re
gula
tion
s / p
olic
ies
No
Dela
yed
rele
ase
of fu
nds
(exc
ept s
alar
ies)
17A
Publ
ic, d
onor
Redi
strib
u-ti
on 7
0%N
oN
o7
tech
nica
l
Insu
ffi c
ient
No
HR
deve
lopm
ent
plan
. No
lega
l sup
port
No
Cons
ulta
tion
on
new
le
gisl
atio
nN
oTa
sks
of t
echn
ical
co
mm
itte
e no
t de
fi ned
25A
Publ
ic, f
ees
Redi
strib
u-ti
on 4
0%N
oN
o13
tech
nica
l
Insu
ffi c
ient
No
orga
nigr
am, j
ob
de sc
ripti
ons
or H
R de
v pl
an
No
Isol
ated
init
iati
ves
(MA/
indu
stry
)N
oIn
tern
al t
echn
ical
co
mm
itte
e, n
o ru
les
WES
T
01A
Publ
ic, d
onor
No
No
27 +
6
Nee
d tr
aini
ng
No
HR
deve
lopm
ent
plan
No
Som
e co
nsul
tati
on
(pro
f. as
soci
atio
ns)
**Fu
ndin
g no
t re
leas
ed
in t
ime.
No
inte
rnet
.
13A
Publ
ic, f
ees,
dono
rYe
s, sp
ecia
l ac
coun
tN
oN
o5
+10
Insu
ffi c
ient
No
orga
nigr
am o
r jo
b de
scrip
tion
s, no
HR
deve
lopm
ent
plan
No
Lim
ited
info
rmat
ion
avai
labl
e; li
ttle
vis
i-bi
lity.
Act
ion
plan
fo
r go
od g
over
nanc
e
No
Dire
ctor
is a
lso
head
of
tend
er b
oard
14A
Publ
icN
o de
tail e
d pl
anN
o15
+10
Nee
d tr
aini
ng
Five
-yea
r pl
an, n
o de
tails
on
fund
ing
Som
e co
nsul
tati
on
(pro
f. as
soci
atio
ns)
No
Very
lim
ited
bud
get
18A
Publ
ic, f
ees
to
gove
rnm
ent
No
No
Bein
g dr
afte
d13
tec
hnic
al
Insu
ffi c
ient
No
HR
deve
lopm
ent
plan
, no
lega
l sup
port
No
Som
e co
nsul
tati
on.
Web
site
nee
ds
regu
lar
upda
tes
Yes
No
proc
edur
es
esta
blis
hed
for
tech
nica
l com
mit
tees
19C
Publ
ic, f
ees
(no
lega
l bas
is),
dono
rYe
s, sp
ecia
l ac
coun
t
? N
ot
back
ed b
y la
wN
o61
Insu
ffi c
ient
No
HR
deve
lopm
ent
plan
, tra
inin
g co
nduc
ted
ad h
oc
Part
ial
(con
fi den
tialit
y on
ly)
Insu
ffi c
ient
con
sul-
tati
on. W
ebsi
te
unde
r co
nstr
ucti
on**
Thre
e un
its
loca
ted
in
diff
eren
t pl
aces
. Boa
rd
not
appo
inte
d.
22A
Publ
ic, f
ees,
dono
rYe
s, ex
cept
lic
ensi
ng
fees
No
No
11 t
echn
ical
Insu
ffi c
ient
No
spec
ifi c
trai
ning
, no
dev
elop
men
t pl
an.
No
orga
nigr
am o
r jo
b de
scrip
t.
No
Acti
on p
lan,
but
no
spec
ifi c
mea
sure
s to
pr
omot
e tr
ansp
aren
cyN
o
Infl e
xibl
e fu
ndin
g al
loca
tion
. Lac
k of
ba
sic
equi
p men
t (c
opy
mac
hine
s, te
leph
one
exch
ange
)
23A
Publ
ic, f
ees
to
gove
rnm
ent
No
No
Bein
g in
itia
ted
9 te
chni
cal
Insu
ffi c
ient
No
HR
dev
plan
No
lega
l sup
port
, eig
ht
vaca
nt p
osts
No
Prof
ess.
coun
cil
repr
esen
tati
on. W
eb-
site
not
mai
ntai
ned.
Yes
No
proc
edur
es
esta
blis
hed
for
tech
nica
l com
mit
tees
24C
Publ
ic, f
ees,
dono
rYe
sN
oYe
s, f
or a
dmin
. pr
oces
ses
Insu
ffi c
ient
No
HR
dev
plan
, No
job
desc
ript.
for
key
staf
fG
ener
al (C
iv.
Serv
.)Si
te n
ot u
pdat
ed.
Litt
le c
onsu
ltat
ion
Yes
Poor
infr
astr
uctu
re a
nd
mai
nten
ance
26
A: G
ove
rnm
ent
Dep
artm
ent
, B: B
oar
d/C
ou
nci
l/B
ody
corp
ora
te, C
: par
asta
tal ag
ency
.
27
** =
Web
site
in
trodu
ced a
fter
vis
it [
11]
***
Web
site
no lon
ger
fou
nd in
2009
p2780851_Flash-OMS-EMPP.indd 2780851_Flash-OMS-EMPP.indd 27 11/12/10 8:33:55 PM11/12/10 8:33:55 PM
28 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
AN
NE
X 4
: Mar
keti
ng a
utho
riza
tion
+=
exi
stin
g, ±
= e
xist
ing
but i
nade
quat
e, −
= n
ot e
xist
ing
Regi
on
Adeq
uate
lega
l ba
sis
Gui
danc
e fo
r ap
plic
ants
SOP
for
asse
ss-
men
t
Advi
sory
co
mm
itte
eEx
tern
al
asse
ssor
sFu
ll tim
e as
ses s
ors
Secu
re
fi lin
g sp
ace
Com
pute
-ri
zed
syst
em
List
of
appr
o-ve
d pr
oduc
ts,
incl
. SPC
Reco
gni t
ion
of
strin
gent
MRA
s’ de
cisi
ons
Gap
s / r
emar
ks
Coun
try
EAST 02
+±I
nade
quat
e± N
ot a
de-
quat
eTe
chni
cal
com
mit
tee
Lim
ited
7In
suffi
cie
nt
±± D
atab
ase,
SI
A MED
(for
so
me
part
s)
List
wit
hout
SP
C or
pac
k si
zes
No
Don
atio
ns e
xem
pt
03+ M
inis
ter=
lice
n-
sing a
uth
ori
ty
±Che
ck lis
ts
± Adm
in
only
Yes,
but
no ti
me/
capa
city
No
4In
suffi
cie
nt±
− N
one
List
not
upd
a-te
d, n
o SP
CN
oSc
reen
ing
only
don
e Br
oad
exem
ptio
ns
04+
± Not
com
pre-
hens
ive
? R
eport
form
at
exis
ts
Inte
rnal
, no
tech
nica
l co
mm
itte
es
No
10
Insu
ffi c
ient
±± S
tand
-alo
ne
data
base
List
not
pub
-lis
hed,
SPC
no
t as
sess
edN
oLo
cal p
rod&
pub
l. se
ctor
ex
empt
. No
spec
ifi c
requ
irem
ents
for
vac
cine
s
06+
− N
one
− N
one
No
No
Insu
ffi c
ient
±−
Non
eLi
st n
ot
publ
ishe
dN
oM
A gr
ante
d w
itho
ut d
ossi
er
eval
uati
on
07+
± Not
co
mpr
ehen
s. N
o gu
idan
ce
on B
E,
stab
ility
− N
one
Not
op
erat
iona
l
Stop
ped
1 ye
ar
befo
re
visi
t, no
fu
nds
Insu
ffi c
ient
±± S
tand
-alo
ne
data
base
List
out
date
d,
not
publ
ishe
dU
S-FD
A, W
HO
-PQ
, EU
Exem
ptio
ns f.
orph
an p
ro du
cts,
publ
ic se
ctor
impo
rts
Asse
ssm
ents
sto
pped
09± R
equi
rem
ents
no
t sp
ecifi
ed± N
ot d
etai
led,
ou
tdat
ed−
Non
eN
ot
oper
atio
nal
Tran
siti
o-na
l, in
acti
ve
3In
suffi
cie
nt±
− N
one
List
exi
sts,
but
no w
ebsi
teCP
P re
ques
ted
No
ongo
ing
eval
uati
on(n
o te
ch. c
apac
ity)
10−
(Pro
pose
d, n
o de
tails
)--
-n/a
---
---n
/a--
---
-n/a
---
---n
/a--
-n/
an/
a--
-n/a
---
---n
/a--
---
-n/a
---
Regu
lato
ry s
yste
m n
ot y
et
esta
blis
hed
15+
+ Det
aile
d in
fo
on for
mat
/
conte
nt
+ Wri
tten
SO
Ps
Yes
Yes
Insu
ffi c
ient
±± n
etw
orke
d M
IS d
'bas
e Li
st w
itho
ut
SPC
Supe
rfl u
ous
step
of
"pre
-re
gist
rati
on"
of g
ener
ics
and
esse
ntia
l med
s
16± A
ct, b
ut n
o re
gula
tion
s±N
ot u
pdat
ed
−Non
eN
ot
oper
atio
nal
Yes
Insu
ffi c
ient
±
± Dat
abas
e;
1 87
8 pe
ndin
g ap
plic
atio
ns
Lim
ited
info
, no
t up
date
dN
ot f
orm
alN
o sp
ecifi
c re
quire
men
ts f
or
vacc
ines
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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29 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
Regi
on
Adeq
uate
lega
l ba
sis
Gui
danc
e fo
r ap
plic
ants
SOP
for
asse
ss-
men
t
Advi
sory
co
mm
itte
eEx
tern
al
asse
ssor
sFu
ll tim
e as
ses s
ors
Secu
re
fi lin
g sp
ace
Com
pute
-ri
zed
syst
em
List
of
appr
o-ve
d pr
oduc
ts,
incl
. SPC
Reco
gni t
ion
of
strin
gent
MRA
s’ de
cisi
ons
Gap
s / r
emar
ks
Coun
try
20+
± Few
g'li
nes,
outd
ated
(1
981)
−Non
eYe
sEx
clu s
ivel
yIn
suffi
cie
nt±
−Non
eN
ot p
ubli s
hed
(200
9: w
eb)
No
No
prov
isio
ns f
. vac
cine
s; n
o gu
idan
ce o
n va
riati
ons
26± N
o de
taile
d le
gal i
nstr
umen
t
+ Tec
hnic
al
info
not
consi
sten
tly
update
d
± Not
for
en
tire
pr
oces
sYe
sN
o6
±± S
IAM
ED
+oth
er
data
base
Not
pub
li she
d (2
009:
web
)CP
P re
view
ed,
not
requ
ired
All o
ral s
olid
dos
e an
ti-
infe
ctiv
es e
xem
pt f
rom
bi
oequ
ival
ence
stu
dies
SOU
TH 11+
+ Det
aile
d in
fo
on for
mat
/
conte
nt
±Che
ck lis
t11
exp
ert
com
mit
tees
Excl
u siv
ely,
Qual
ifi ed
ex
pert
s
Non
e
Insu
ffi c
ient
+± S
tand
-alo
ne
data
base
sLi
st w
itho
ut
SPC
Yes,
defi n
ed li
st o
f M
RAs
Rem
u ner
atio
n is
sues
, del
ays.
Asse
ssm
ents
tak
e 12
-24
mon
ths
21+
± Not
com
pre-
hen s
ive
E.g
no
guid
e lin
e fo
r re
new
al
−Non
eYe
sYe
sAl
l par
-ti
cipa
te
Insu
ffi c
ient
±−N
one
Out
date
d lis
tD
ecis
ions
fro
m
othe
r N
MRA
s re
ques
ted
Proc
ess
can
take
5 y
ears
Back
log
of a
ppro
x. 1
000
appl
icat
ions
MID
DLE
05± A
ct, b
ut n
o re
gula
tion
s−N
one
−Non
eN
oN
oIn
suffi
cie
nt±
−Non
eN
oN
oSy
stem
not
yet
ope
ra ti
o nal
. D
ona t
ions
exe
mpt
08+
+ Val
ida t
ed
SOPs
7 sp
ecia
lized
1
natio
nal
Yes
4
Suf
fi cie
nt±
+SIA
MED
CPP
requ
este
dN
o pr
oced
ure
for
vete
rinar
y pr
oduc
ts
12+
−Non
eN
ot f
or M
A sp
ecifi
cally
No
3
Insu
ffi c
ient
±−N
one
No
regu
lati
ons
for
vacc
i nes
, re
agen
ts, v
et m
eds
17+
± Adm
in
only
Yes
Yes
2
Insu
ffi c
ient
++S
IAM
ED
No
proc
edur
es f
or t
echn
ical
ev
alua
tion
25
+ Bri
ef d
escr
ip ti
on
of
requi-
red d
oss
ier
com
ponen
ts
± Not
det
aile
d,
outd
ated
−Non
eU
noffi
cia
lN
o14
Insu
ffi c
ient
±± G
IRAP
H,
not
opti
mal
Yes;
SPC
not
in
clud
ed in
re
gist
rati
on
cert
ifi ca
te
CPP
requ
este
dM
ainl
y ad
min
istr
ativ
e re
view
. Fe
w re
quire
men
ts f
or g
ener
ics
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30 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
Regi
on
Adeq
uate
lega
l ba
sis
Gui
danc
e fo
r ap
plic
ants
SOP
for
asse
ss-
men
t
Advi
sory
co
mm
itte
eEx
tern
al
asse
ssor
sFu
ll tim
e as
ses s
ors
Secu
re
fi lin
g sp
ace
Com
pute
-ri
zed
syst
em
List
of
appr
o-ve
d pr
oduc
ts,
incl
. SPC
Reco
gni t
ion
of
strin
gent
MRA
s’ de
cisi
ons
Gap
s / r
emar
ks
Coun
try
WES
T
01+B
rief
outl
ine
± Brie
f, no
te
ch ni
cal
guid
ance
+ Ma nual &
guid
eYe
sYe
s4
Suf
fi cie
nt+
+SIA
MED
CP
P re
ques
ted
Vacc
ines
not
regu
late
d by
MRA
13± I
nco
mple
te a
nd
outd
ate
d r
egula
-
tions
± Not
su
ffi c
ient
ly
deta
iled,
ou
tdat
ed
± Adm
in
only
Yes
(no
spec
ifi c
expe
rtis
e)
Yes,
and
QC
lab
staf
f
3In
suffi
cie
nt±
+SIA
MED
SPC
not
incl
uded
in
regi
stra
tion
ce
rtifi
cate
No
Mai
nly
adm
inis
trat
ive
revi
ew. S
ome
dona
tion
s an
d in
vest
igat
iona
l pro
duct
s ex
empt
14± D
atin
g fr
om
1994
±Som
e± I
nfor
mal
in
tern
al
doc
Yes;
no
spec
ializ
ed
com
mit
tees
Yes
(few
)4
Insu
ffi c
ient
±− M
anua
l on
ly; m
ajor
pr
oble
m
List
not
pub
-lis
hed,
SPC
no
t as
sess
ed
Rene
wal
of
MA
not
follo
wed
up
by
NM
RA o
r ap
plic
ants
18+
± Reg
ulat
ion
and
Circ
ular
± Adm
in
only
Yes
Yes
Insu
ffi c
ient
++ S
IAM
ED
(back
log)
2009
: Lis
t on
web
site
(no
SPC)
No
No
proc
edur
es f
or t
echn
ical
ev
alua
tion
19± I
ncom
ple t
e re
gula
tion
s± N
ot c
ompr
e-he
nsiv
e±S
ome
Info
rmal
Yes
10In
suffi
cie
nt±
−Non
eDe
c 09
: list
of
Oct 0
8 on
web
-sit
e, no
SPC
No
Lack
of
asse
ssor
s a
maj
or
prob
lem
; pro
ce du
res
need
im
prov
emen
t
22+
± Not
su
ffi c
ient
ly
deta
iled,
ou
tdat
ed
± Adm
in
only
Yes
(few
m
eeti
ngs,
dela
ys)
No
1In
suffi
cie
nt±
± Exc
el, n
ot
netw
orke
d
Regi
stra
tion
ce
rtif
. has
lim
i ted
in
form
atio
n
No
Mai
nly
adm
inis
trat
ive
revi
ew.
Lack
of
spec
ifi c
skill
s an
d in
form
atio
n
23+
± Circ
ular
de
scrib
ing
the
proc
ess
± Adm
in
only
Nat
iona
l co
mm
itte
eYe
s2
Insu
ffi c
ient
±
+SIA
MED
N
oTe
chni
cal p
roce
dure
s ne
ed
impr
ovem
ent
24+
? G
uid
ance
has
bee
n
publish
ed
± Adm
in
only
No
Vario
us
in te
r nal
co
m-
mit
tees
Insu
ffi c
ient
±± D
atab
ase
netw
orke
d w
ithi
n de
pt.
List
gaz
ette
d,
web
not
up
date
d, n
o SP
C
Yes,
coun
try
of
orig
inD
onat
ions
, orp
han
med
icin
es
exem
pt
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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31 As se s s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
AN
NE
X 5
: Lic
ensi
ng o
f ac
tivi
ties
= N
MRA
; a
noth
er b
ody,
= tw
o ot
her b
odie
s, =
NM
RA a
nd a
noth
er b
ody,
= N
MRA
and
two
othe
r bod
ies,
= n
ot a
ssig
ned
to a
spe
cifi c
bod
y
Regi
onAu
tho r
ity
Des
crip
tion
, gap
sCo
untr
y
EAST 02
Ap
prov
al t
o m
anuf
actu
re is
gra
nted
on
a pr
oduc
t-by
-pro
duct
bas
is; m
anuf
actu
rers
are
sup
port
ed t
o m
eet
min
imum
GM
P st
anda
rds.
03
Cont
rol b
y tw
o di
ffer
ent
com
mit
tees
(one
for
man
ufac
ture
rs /
dist
ribut
ors,
anot
her
for
reta
il), s
ome
rene
wal
s w
itho
ut in
spec
tion
s. S
ome
faci
litie
s op
erat
e un
der
locu
m
phar
mac
ists
for
mon
ths.
List
of
licen
sed
busi
ness
es n
ot r
eadi
ly a
vaila
ble
04
NM
RA c
erti
fi es
com
pete
nce
(pub
lic s
ecto
r ex
empt
), li
cens
e by
Min
istry
of T
rade
. G
MP
not
in li
ne w
ith
WH
O s
tand
ards
. Ret
ail:
regi
onal
con
trol
but
repo
rtin
g sy
stem
not
fi na
lized
. Poo
r coo
pera
tion
with
oth
er n
atio
nal e
nfor
cem
ent a
genc
ies (
cust
oms,
polic
e).
06
Lice
nce
requ
ired
by la
w, b
ut re
gula
tion
s ex
ist
for
phar
mac
ies/
depo
ts o
nly
07N
atio
nal a
nd R
egio
nal M
oH (n
o of
fi cia
l del
egat
ion
to t
he la
tter
, no
regu
lar
repo
rtin
g sy
stem
). Li
cenc
es h
ave
no v
alid
ity
date
. Pub
lic h
ospi
tal p
harm
acie
s ex
empt
. 09
Min
istr
y of
Pub
lic H
ealt
h on
Insp
ecto
rate
's ad
vice
; few
req
uire
men
ts f
or m
anuf
actu
rers
and
dis
trib
utor
s10
(Ret
aile
rs in
spec
ted
by P
ublic
Hea
lth
insp
ecto
r)
15Sc
atte
red
resp
onsi
bilit
ies:
Dep
2,3,
6 (lo
cal m
anuf
actu
rers
), D
ep6
(for
eign
man
ufac
ture
rs)
Dep
3+re
gion
al a
utho
ritie
s (r
etai
l)16
Regu
lati
ons
on c
ontr
ols
of d
istr
ibut
ion
chan
nels
not
ena
cted
20N
MRA
& Q
C La
b (f
or m
anuf
actu
rers
& re
tail)
- c
onfl i
ctin
g re
spon
sibi
litie
s; u
ncle
ar e
xem
ptio
ns (e
.g. h
ospi
tal p
harm
acie
s). M
oH In
spec
tora
te (f
or d
istr
ibut
ors)
. 26
N
MRA
(man
ufac
ture
rs &
dis
trib
utor
s). M
oH li
cens
es p
ri va t
e ph
arm
acie
s, no
rul
es f
or p
ublic
hos
pita
l pha
rmac
ies
SOU
TH 11N
MRA
(in
conn
ecti
on w
ith
MA)
Prof
essi
onal
cou
ncil
(for
est
ablis
hmen
ts)
21M
oH (l
icen
ces
issu
ed b
y M
in. T
rade
) Pub
lic h
ealt
h fa
cilit
ies
and
disp
ensi
ng d
octo
rs n
ot in
spec
ted
MID
DLE
05
Cont
rol b
y N
atio
nal H
ealt
h In
spec
tora
te +
Min
istr
y of
Com
mer
ce, b
ut n
o en
ablin
g re
gula
tion
s on
goo
d pr
acti
ces
for
man
ufac
turin
g, s
ale
and
disp
ensi
ng08
N
MRA
(pre
para
tion
), M
inis
try
Pub
Hea
lth
(ret
aile
rs).
Prof
essi
onal
cou
ncil
(man
ufac
ture
rs, d
istr
ibut
ors,
impo
rter
s)
12
Cont
rol b
y th
ree
diff
eren
t de
part
men
ts, d
epen
ding
on
prod
uct
type
Som
e ph
arm
acie
s ha
ve m
unic
ipal
app
rova
l onl
y17
N
MRA
(for
man
ufac
ture
rs, d
istr
ibut
ors,
reta
ilers
). Pr
ofes
sion
al c
ounc
il le
vies
fee
for
reta
ilers
, no
cont
rol o
f m
edic
ine
shop
s
25M
oH, o
n ad
vice
of
NM
RA a
nd H
ealt
h in
spec
tora
te.
Requ
irem
ents
not
defi
ned
WES
T01
Cont
rol b
y tw
o di
ffer
ent
depa
rtm
ents
, dep
endi
ng o
n pr
oduc
t ty
pe. N
o G
MP
insp
ecti
ons
13Ap
prov
al b
y M
inis
ter
of H
ealt
h on
adv
ice
of p
rofe
ssio
nal c
ounc
il an
d te
chni
cal c
omm
itte
e. In
spec
tion
onl
y af
ter
licen
ce is
gra
nted
. GDP
not
req
uire
d fo
r di
stri
buto
rs. S
ome
unlic
ense
d fa
cilit
ies
(e.g
. fai
th-b
ased
)
14
Cont
rol b
y tw
o di
ffer
ent
depa
rtm
ents
(one
for
man
ufac
ture
rs, a
lso
task
ed t
o pr
omot
e lo
cal i
ndus
try,
ano
ther
for
dis
trib
utor
s an
d re
taile
rs).
Inad
equa
te in
form
atio
n m
anag
emen
t.18
N
o op
erat
ing
proc
edur
es
19
NM
RA +
insp
ecto
rs f
rom
oth
er d
epar
tmen
ts (f
or m
anuf
actu
rers
)
Prof
essi
onal
Cou
ncil
(for
dis
trib
utor
s, re
taile
rs)
22M
oH o
n ad
vice
of N
MRA
, Ins
pect
orat
e, P
rofe
ssio
nal C
ounc
ils. N
o sp
ecifi
c re
gula
tions
for v
ario
us ty
pes o
f est
ablis
hmen
ts. G
SP re
quire
d bu
t not
pub
lishe
d. S
ome
unlic
ense
d di
stri
buto
rs.
23N
o SO
Ps in
pla
ce f
or li
cens
ing
24
Phar
mac
euti
cal a
ctiv
itie
s co
ntro
lled
by p
rofe
ssio
nal c
ounc
il (n
o lic
ensi
ng f
or m
anuf
actu
rers
of
inve
stig
atio
nal p
rodu
cts)
p3180851_Flash-OMS-EMPP.indd 3180851_Flash-OMS-EMPP.indd 31 11/12/10 8:36:21 PM11/12/10 8:36:21 PM
32 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
AN
NE
X 6
: Im
port
con
trol
Regi
onD
escr
ipti
on, g
aps
Coun
try
EAST 02
Cont
rol o
f AP
Is a
nd F
PPs
by re
view
ing
pro-
form
a in
voic
es
03Im
port
: Not
enf
orce
d, n
o in
spec
tion
sys
tem
; pro
duct
s fo
r sp
ecifi
c pa
tien
ts e
xem
pt. E
xpor
t: n
o le
gal r
equi
rem
ents
04Sp
ecifi
c pr
ovis
ions
on
impo
rt /e
xpor
t ex
ist
for
narc
otic
s on
ly. I
mpo
rt b
ased
on
nati
onal
med
icin
es li
st o
r w
ritte
n re
ques
t by
a d
octo
r
06Li
cens
ed e
stab
lishm
ents
can
impo
rt p
harm
aceu
tica
ls w
itho
ut a
ny r
equi
rem
ents
07M
A no
t re
quire
d fo
r pu
blic
sec
tor
impo
rts;
no
actu
al in
spec
tion
09N
MRA
, bas
ed o
n M
A (n
o lis
t of
lice
nsed
dis
tri b
utor
s). P
rivat
e co
mpa
ny c
ontr
ols
impo
rt a
cts
and
prep
ares
doc
umen
tati
on.
10Im
port
con
trol
not
yet
impl
emen
ted
15M
A ne
eded
, but
no
list
of e
xem
p t p
rodu
cts
16Le
gal b
asis
but
no
regu
lati
ons
enac
ted
20N
o w
ritte
n gu
idel
ines
for
impo
rt /
expo
rt li
cenc
es; l
ist
of li
cens
ed im
port
ers
and
expo
rter
s no
t re
adily
ava
ilabl
e
26An
nual
lice
nce
& v
erifi
cati
on o
f ea
ch im
port
. Les
s co
ntro
l for
unr
egis
tere
d pr
oduc
ts
SOU
TH 11Im
port
ed p
rodu
cts
need
MA;
NM
RA re
view
s Co
As
21Im
port
ed/e
xpor
ted
prod
ucts
nee
d M
A. P
rodu
cts
impo
rted
by
Cent
ral M
edic
al S
tore
s an
d
dona
ted
drug
s ar
e ex
empt
ed f
rom
regi
stra
tion
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p32 80851_Flash-OMS-EMPP.indd 3280851_Flash-OMS-EMPP.indd 32 11/12/10 8:36:25 PM11/12/10 8:36:25 PM
33 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
Regi
onD
escr
ipti
on, g
aps
Coun
try
MID
DLE
05N
o sp
ecifi
c re
quire
men
ts t
o co
ntro
l im
port
of
APIs
, no
cert
ifi ca
tion
of
expo
rts
08 12Ap
prox
. 90%
of
prod
ucts
impo
rted
.
1710
0% o
f pr
oduc
ts im
port
ed. S
ince
200
7 im
port
atio
n on
ly t
hrou
gh li
cens
ed w
hole
sale
rs, b
ut n
ot c
ontr
olle
d in
pra
ctic
e
25Im
port
ed p
rodu
cts
need
MA,
but
som
e ex
cept
ions
. NM
RA a
utho
rizes
impo
rts
for
spec
ifi c
trea
tmen
t ne
eds
wit
hout
offi
cia
l del
egat
ion
and
wit
hout
defi
ned
pro
ce du
re. L
ack
of r
egul
atio
n fo
r do
nati
ons.
Exp
ort
not
regu
late
d
WES
T
0198
% o
f m
edic
ines
impo
rted
. Reg
ulat
ions
to
be a
dopt
ed
13W
ide
rang
e of
aut
hori
zed
impo
rter
s; n
o sy
stem
to
keep
tra
ck o
f pr
oduc
t st
atus
(MA)
, reg
ulat
ions
not
ade
quat
e to
con
trol
don
atio
ns
14Ba
sed
on M
A, b
ut n
o co
mpu
teri
zed
lists
18La
ck o
f co
ntro
l for
inve
stig
atio
nal p
rodu
cts
19Im
port
ers
licen
sed
by p
rofe
ssio
nal c
ounc
il; N
MRA
has
no
lega
l bas
is f
or in
spec
tion
22N
eed
appr
oval
by
MoH
on
advi
ce o
f N
MRA
. No
syst
em t
o ve
rify
lot
num
bers
, aut
hori
zed
impo
rter
s, r
egis
tere
d pr
oduc
ts. N
o ac
tive
col
labo
rati
on w
ith
cust
oms
23M
A ne
eded
, but
exe
mpt
ions
unc
lear
24O
nly
licen
sed
esta
blis
hmen
ts c
an im
port
. NRA
scr
eens
doc
umen
ts, s
ome
insp
ecti
ons/
tes
ting
p3380851_Flash-OMS-EMPP.indd 3380851_Flash-OMS-EMPP.indd 33 11/12/10 8:36:28 PM11/12/10 8:36:28 PM
34 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
AN
NE
X 7
: Ins
pect
ions
= N
MRA
; a
noth
er b
ody,
= N
MRA
and
ano
ther
bod
y+=
exi
stin
g; ±
= e
xist
ing
but i
nade
quat
e, −
= n
ot e
xist
ing
Regi
onAu
thor
ity
/ ies
in c
harg
eLe
gal b
asis
GM
P re
quire
d
Publ
ishe
d G
MP
guid
elin
es
Publ
ishe
d G
DP
guid
elin
es
SOP
for
insp
ecti
onQ
MS
Insp
ec to
rsIn
spec
-to
rs
Lo gi
s-ti
csM
ain
gaps
/ re
mar
ksCo
untr
y
EAST 02
+
regio
nal offi
cer
s+
Yes
± Not
to
WH
O
stan
dard
sN
one
±Che
cklis
t−
10
+reg
iona
l+
±Po
or c
oord
ina t
ion,
inex
perie
nced
in
spec
tors
03+
Bein
g ph
ased
in−N
one
±Che
cklis
t, ou
tdat
ed−
2 +4
as
sist
ants
±±
Phar
mac
ists
fro
m d
istr
ibut
ion
chan
nels
do
insp
ecti
ons:
con
fl ict
of
inte
rest
04
+ R
egio
nal
bra
nch
es
± No
spec
if. p
ro -
visio
ns to
con
-tr
ol a
ctiv
ities
No
± Not
to
WH
O
stan
dard
sN
one
±Che
cklis
t−
10 p
h'ci
sts
(cen
tral
le
vel)
±±
Lack
of
staf
f, tr
aini
ng, e
xper
ienc
e an
d re
sour
ces
06
+
Yes
(no
re-
gula
tion
s)−N
one
Non
e−N
one
−2
±±
Lack
of
staf
f an
d re
sour
ces,
not
func
tion
al
07+
Reg
ional M
oH
inoffi
cia
l)+
Yes
−Non
eN
one
±Che
cklis
t−
3±
±La
ck o
f tr
ansp
ort
a m
ajor
pro
blem
09
Public
hea
lth
in sp
ec to
rate
+N
o−N
one
Non
e±C
heck
list
−6
±±
Seve
re la
ck o
f qu
alifi
ed s
taff
Del
ays
in re
leas
e of
fun
ds
10
Hea
lth insp
ecto
r± P
harm
a cie
s on
lyn/
an/
an/
a1
±±
Insp
ecti
ons
of p
harm
acie
s w
ere
the
only
regu
lato
ry f
unct
ion
15
+ R
egio
nal +
QC
L
staff
+Ye
s± W
orke
d ou
t by
loca
l co
mm
itte
e16
±±
Larg
e di
ffer
ence
s in
str
inge
ncy
betw
een
regi
ons
16
+R
egio
nal
±No
regu
lati
ons
Not
for
M
A± N
ot t
o W
HO
st
anda
rds
−Non
e−
6 +1
7 pa
rt
tim
e±
±St
aff,
fund
s an
d G
MP
trai
ning
ne
eded
. No
rout
ine
insp
ecti
ons
20+
MoH
+Q
C s
taff
+N
o+ W
HO
tex
t, na
t. dr
aft
unfi n
ishe
dN
one
−Non
e−
4±
±Fe
w in
spec
tion
s. N
o pl
an f
or f
ollo
w-
up
26
+ R
egio
nal st
aff
+N
o
− Unp
ub-
lishe
d dr
aft
mod
eled
on
PIC/
S
Non
e±C
heck
list
−33
+65
re
gion
al+
+H
ospi
tal p
harm
acie
s no
t re
gula
rly
insp
ecte
d
SOU
TH 11+
Pro
fess
ional
counci
l+
Yes
+Ye
s±O
utda
ted
−To
be
set
up
NM
RA: 1
0
Coun
cil:
34
part
-tim
e
++
NM
RA n
ot in
cha
rge;
Pro
fess
. cou
ncil
mak
es fi
nal d
ecis
ion
base
d on
GM
P in
spec
tion
repo
rts,
and
insp
ects
di
strib
utio
n ch
ain
21
− (Fu
ncti
on n
ot
men
tion
ed in
Ac
t)Ye
s−N
one
Non
e±C
heck
list
−N
o±
±La
ck o
f re
sour
ces,
no re
spon
sibl
e pe
rson
. Pub
l. se
ctor
out
lets
& d
is pe
ns.
doct
ors
not
insp
ecte
d
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p34 80851_Flash-OMS-EMPP.indd 3480851_Flash-OMS-EMPP.indd 34 11/12/10 8:36:33 PM11/12/10 8:36:33 PM
35 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
Regi
onAu
thor
ity
/ ies
in c
harg
eLe
gal b
asis
GM
P re
quire
d
Publ
ishe
d G
MP
guid
elin
es
Publ
ishe
d G
DP
guid
elin
es
SOP
for
insp
ecti
onQ
MS
Insp
ec to
rsIn
spec
-to
rs
Lo gi
s-ti
csM
ain
gaps
/ re
mar
ksCo
untr
y
MID
DLE
05
Pub H
ealt
h
insp
ecto
rate
+reg
ional st
aff
+N
o (p
ropo
sed
for
MA)
±Not
to
WH
O
stan
dard
sN
one
−Non
e−
69
+±
Insp
ecto
rate
not
wel
l equ
ippe
d.
To s
erve
as
enfo
rcem
ent
arm
for
pr
opos
ed N
MRA
08
MoH
in sp
ecto
rate
+N
o−N
one
Non
e−N
one
−±
±La
ck o
f st
aff
and
reso
urce
s, po
or
coor
dina
tion
wit
h N
MRA
12
Sev
eral N
RA
dep
art
men
ts
+re
gio
nal
± Not
spe
cifi c
to
typ
es o
f in
spec
tion
No
−Non
eN
one
−Non
e−
24±
±La
ck o
f st
aff
and
reso
urce
s; n
o re
port
s
17± N
o in
spec
tors
’ st
atus
N
o−N
one
Non
e±C
heck
list
−+
±La
ck o
f re
sour
ces
25D
ivis
ion o
f
Public
Hea
lth
Insp
ecto
rate
+N
o−N
one
Non
e−N
one
−±
±La
ck o
f st
aff
and
reso
urce
s
WES
T
01
Public
Hea
lth
Insp
ecto
rate
+N
o±N
ot t
o W
HO
st
anda
rds
Not
to
WH
O
stan
dard
s−N
one
−2
±±
Lack
of
staf
f an
d re
sour
ces,
poor
co
ordi
nati
on w
ith
NM
RA
13In
spec
tors
nam
ed
by
Min
Pub
Hea
lth
± Ins
pect
ors'
pow
ers
not
wel
l de
fi ned
Yes
−Non
e−N
one
±Che
cklis
t−
4 (in
cl.
one
from
N
MRA
)±
±Re
port
s ad
dres
sed
to M
in P
ub H
ealt
h.
Annu
al p
lan
not
fulfi
lled
due
to la
ck
of in
spec
tors
and
reso
urce
s
14+
MoH
± Res
pons
i bili
ties
no
t cl
ear
No
+WH
O t
ext
WH
O t
ext
−Non
e−
27;
2 fr
om
Min
istr
y of
he
alth
±±
Lack
of
staf
f. Af
fi lia
tion
of
insp
ecto
rs
uncl
ear
18
Hea
lth I
n-
spec
tora
te+
?
Not
for
M
A
−Non
eN
one
+Yes
10±
±An
nual
pla
ns n
ot m
et d
ue t
o la
ck o
f st
aff
and
reso
urce
s
19+
Pro
fess
ional
Counci
l+
No
+WH
O t
ext
? (C
ontr
ol
by C
ounc
il)
± Not
co
mpr
e-he
nsiv
e−
6 +f
rom
ot
her
dep
±±
Lack
of
staf
f an
d re
sour
ces.
Coun
cil
lack
s re
sour
ces
to c
arry
out
its
man
date
22+
Hea
lth
Insp
ecto
rate
± Som
e re
gu-
la ti
ons
not
publ
ishe
d
Yes (
regu
-la
tion
not
publ
ished
)−N
one
Non
e−N
one
−?
Non
e fr
om
NM
RA±
±N
o le
gally
em
pow
e red
NM
RA
insp
ecto
rs, i
nspe
ctor
ate
staf
f no
t ph
arm
acis
ts
23+
Yes
+N
one
+ Yes
, not
validate
d−
±±
Lack
of
staf
f; G
MP
trai
ning
nee
ded
24+
Pro
fess
ional
Counci
l+
Yes
(no
regu
la-
tions
) −N
one
Non
e±C
heck
list
−53
8±
±O
verla
p of
act
ivit
ies
(NM
RA/C
ounc
il)
– gr
ey a
reas
p3580851_Flash-OMS-EMPP.indd 3580851_Flash-OMS-EMPP.indd 35 11/12/10 8:36:36 PM11/12/10 8:36:36 PM
36 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
AN
NE
X 8
: Qua
lity
cont
rol
= N
MRA
; =
ano
ther
bod
y, =
two
othe
r bod
ies,
= n
o Q
C la
b;
+= e
xist
ing,
± =
exi
stin
g bu
t ina
dequ
ate,
−=
not
exi
stin
g;
----
---=
no
QC
lab
(not
revi
ewed
)
Regi
onDe
scri
ptio
n of
reg
ulat
ory
QC
labo
rato
ryQ
ualit
y m
anag
e men
t sy
stem
St
aff
(tec
h+ad
min
)
Equi
pmen
t
& m
aint
enan
ceCo
untr
y
EAST 02
NM
RA d
epar
tmen
t. Te
sts
pre-
mar
keti
ng s
ampl
es
+Can b
e st
rength
ened
+(13 t
ech.)
+
03H
ouse
d at
Cen
tral
Med
Sto
res;
mai
nly
test
s pu
blic
. sec
tor
impo
rts
− Not
fun
ctio
nal (
som
e SO
Ps)
±±I
nade
quat
e
04N
MRA
dep
artm
ent.
Test
s pr
e-m
arke
ting
sam
ples
. − N
o w
ritte
n sy
s tem
, no
SOPs
±(16
tec
h, la
ck o
f ski
lls)
± Lac
king
som
e m
ajor
eq
uipm
ent
06N
one.
Ext
erna
l lab
s us
ed--
----
---
----
---
----
-
07N
atio
nal Q
C la
b. N
o lin
k w
ith
NM
RA. T
ests
pub
lic s
ecto
r im
port
s± I
n fi r
st s
tage
of
impl
emen
tati
on+(
20 +
6)+ L
ack
of sp
ace/
mai
nten
ance
09Ex
tern
al (c
ostl
y, d
elay
s); N
atio
nal H
ealt
h In
stit
ute
(not
yet
set
up)
----
---
----
---
----
---
10(N
one,
NM
RA n
ot in
pla
ce)
----
---
----
---
----
---
15Af
fi lia
ted
wit
hout
lega
l bas
is. P
re-m
arke
t Q
C fo
r ea
ch b
atch
, not
effi
cie
nt. L
ack
of
fund
s+ A
spir
ing t
o I
SO
17025
cert
ifi c
at.
+(33+
3)
+Lack
of
space
16N
ot o
pera
tion
al s
ince
199
9; n
ew la
bora
tory
pro
pose
d--
----
---
----
---
----
-
20Au
tono
mou
s la
b, s
taff
sec
onde
d by
MoH
− Rep
orte
dly
bein
g de
velo
ped
? (1
1 te
ch)
+
26Te
sts
fi rst
3 b
atch
es o
f al
l loc
al p
rodu
ctio
n+ Q
Manual and s
ever
al SO
Ps
+(12 t
ech)
+Lack
of
space
SOU
TH 11M
oH la
b/ac
adem
ia/p
rivat
e; C
ontr
acti
ng-o
ut d
isco
ntin
ued
----
---
----
---
----
---
21Ce
ntra
l Med
ical
Sto
res
lab;
no
lega
l bas
is?
(10
tech
)±B
asic
MID
DLE
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p36 80851_Flash-OMS-EMPP.indd 3680851_Flash-OMS-EMPP.indd 36 11/12/10 8:36:57 PM11/12/10 8:36:57 PM
37 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
Regi
onDe
scri
ptio
n of
reg
ulat
ory
QC
labo
rato
ryQ
ualit
y m
anag
e men
t sy
stem
St
aff
(tec
h+ad
min
)
Equi
pmen
t
& m
aint
enan
ceCo
untr
y
05N
one;
sol
e m
anuf
actu
rer's
lab
used
----
---
----
---
----
---
08N
at.L
ab; t
ests
pre
-MA
sam
ples
+Re
s Cen
tre
(poo
r coo
rdin
a tio
n) +
12N
one,
4 a
ppro
ved
labs
con
trac
t ed
by M
in P
ub H
ealt
h--
----
---
----
---
----
-
17N
one,
out
side
labs
use
d; Q
C la
b to
be
set
up b
y 20
10--
----
---
----
---
----
-
25N
one,
ext
erna
l lab
s us
ed. S
tudy
to
set
up Q
C la
b un
der
way
----
---
----
---
----
---
WES
T
01N
at. P
ublic
Hea
lth
lab.
Tes
ts p
re-m
arke
ting
sam
ples
±L
ack
of s
kills
±Not
opt
imal
ly u
sed
13 N
atio
nal l
ab; w
ide
rang
e of
tas
ks−S
ome
SOPs
+(
Exce
pt f
or b
iolo
gica
ls)
+ Lac
k of
spa
ce; b
eing
re
hous
ed
14N
atio
nal l
ab, t
ests
sam
p les
for
MA.
Man
y ot
her
func
tion
s. ± B
eing
set
up,
par
tly
func
tion
al+
±Mos
tly
old
18N
atio
nal Q
C La
b, t
ests
pre
-mar
keti
ng s
ampl
es
−Will
be
set
up+(
12 t
ech)
+
19N
MRA
Lab
ser
vice
±No
resp
on si
ble
pers
on+
+Lac
k of
spa
ce
22N
atio
nal l
ab+W
HO
/ISO
170
25 s
tandar
ds
+(Exc
ept
for
bio
logic
als
)+ L
ack
of
envi
ron m
enta
l
contr
ol
23N
atio
nal l
ab, r
ecei
ves
doss
iers
and
tes
ts s
ampl
es+ M
anual/
SO
Ps
base
d o
n
OEC
D+(
16 t
ech)
+
24Ye
s (n
ot re
view
ed d
urin
g vi
sit)
Test
s pr
e-m
arke
ting
sam
ples
Not
revi
ewed
Not
revi
ewed
Not
revi
ewed
p3780851_Flash-OMS-EMPP.indd 3780851_Flash-OMS-EMPP.indd 37 11/12/10 8:37:00 PM11/12/10 8:37:00 PM
38 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
AN
NE
X 9
: Mar
ket
surv
eilla
nce
= N
MRA
; =
ano
ther
bod
y, =
not
ass
igne
d to
any
offi
cial
bod
y;
+
= e
xist
ing,
± =
exi
stin
g bu
t ina
dequ
ate,
−=
not
exi
stin
g
Regi
onPr
oduc
t qu
alit
y Pr
oduc
t qu
alit
y m
onit
orin
g m
onit
orin
g Q
C te
stin
g of
Q
C te
stin
g of
sa
mpl
essa
mpl
esAn
ti-c
ount
erfe
itin
g An
ti-c
ount
erfe
itin
g pr
ogra
mm
epr
ogra
mm
eN
MRA
pro
ce du
re f
or
NM
RA p
roce
dure
for
ef
fect
ive
reca
llef
fect
ive
reca
ll
Phar
mac
ovig
ilanc
e sy
stem
Ph
arm
acov
igila
nce
syst
em
*=m
embe
r of
WH
O P
rogr
amm
e f.
*=m
embe
r of
WH
O P
rogr
amm
e f.
Int'l
Dru
g M
oni t
orin
g at
tim
e of
vis
it
Int'l
Dru
g M
oni t
orin
g at
tim
e of
vis
it
(htt
p://w
ww
.who
-um
c.or
ght
tp://
ww
w.w
ho-u
mc.
org/
) )
Cont
rol o
f pr
omot
ion
Cont
rol o
f pr
omot
ion
Meds in formation Meds in formation
Coun
try
EAST 0202
+ Sam
ple
s co
llec
ted a
nd
test
ed
± Sur
veill
ance
for
cou
nter
-fe
its
(to
be s
tren
gthe
ned)
−Non
e±*
Man
ual r
ecor
ding
, res
ults
sen
t to
W
HO
-UM
C. 8
2 re
port
s re
ceiv
ed in
ye
ar b
efor
e vi
sit.
± Not
alw
ays
effe
ctiv
e; S
PC n
ot
avai
labl
e. M
ed. r
eps
subj
ect
to
cont
rol
++
0303− N
o PM
S sy
stem
(in
prep
arat
ion)
Few
Few
± Sur
veill
ance
by
insp
ecto
rs,
no s
peci
fi c p
rogr
amm
e− L
egal
pro
visi
on n
ot
impl
emen
ted
−No
syst
em−N
ot im
plem
ente
d−−
0404−N
o PM
S sy
stem
In c
ase
of
In c
ase
of
com
plai
nts
com
plai
nts
−Non
e± R
epor
ts re
ceiv
ed, l
ack
of e
x per
ts f
or
asse
ssm
ent.
± Gui
delin
es n
ot fi
naliz
ed; n
ot b
ased
on
app
rove
d pr
oduc
t in
fo++
0606−N
o PM
S sy
stem
In c
ase
of
In c
ase
of
com
plai
nts
com
plai
nts
−Non
e−N
one
−Not
est
ablis
hed
−No
regu
lati
ons,
not
oper
atio
nal
−−
0707− N
ot im
plem
ente
d, la
ck o
f in
spec
tors
and
tra
nspo
rtN
one
Non
e co
nduc
ted
co
nduc
ted
−N
one
±* M
oH C
entr
e. P
ublic
sect
or, s
e lec
ted
dist
ricts
. Res
ults
sent
to W
HO
-UM
C.
No
link
with
NM
RA
− Som
e le
gal r
equi
rem
ents
, but
no
cont
rol i
n pr
acti
ce
0909−N
o PM
S sy
stem
"If
need
ed"
"If
need
ed"
−Non
e−N
one
−No
syst
em−N
one
−−
1010−N
o PM
S sy
stem
− Non
e. U
nreg
u lat
ed p
rices
fu
el t
he il
licit
mar
ket
−No
NM
RA−N
o sy
stem
−Non
e−−
1515+ S
am
ple
s su
bm
itte
d
by
public
store
s, U
N
agen
cies
, N
GO
s
−Non
e±N
ot c
ompr
e hen
sive
±*
New
ly in
trod
uced
; thr
ee re
port
s tr
ansm
itte
d to
WH
O-U
MC,
tra
inin
g un
der
way
− Leg
al b
asis
exi
sts,
res p
on si
bilit
y ne
wly
as
sign
ed w
ithi
n N
MRA
1616−N
ot o
pera
tion
al−N
one
+ SO
P; f
ol lo
w-u
p du
ring
insp
ecti
ons
− Vag
ue le
gal b
asis
: "m
onit
orin
g sa
fety
". N
o ac
tivi
ty−L
egal
bas
is b
ut n
ot im
plem
ente
d−−
2020± A
d ho
c ba
sed
on f
eed-
back
fro
m t
he m
arke
tIn
cas
e of
In
cas
e of
co
mpl
aint
sco
mpl
aint
s−N
one
−Non
e− U
nit
esta
blis
hed,
no
acti
vity
(la
unch
ed Ju
ne 2
009)
± Gui
delin
es b
ut n
o sy
stem
atic
m
onit
orin
g
2626+ S
am
ple
s purc
hase
d
regula
rly
from
the
mark
et
and
min
ilabs
an
d m
inila
bs
(reg
iona
l)(r
egio
nal)
± Mar
ket
surv
eilla
nce
by
insp
ecto
rs+S
OP
±* V
ague
lega
l bas
is. R
epor
ting
of
adve
rse
even
ts s
ince
200
8.Re
sult
s se
nt t
o W
HO
-UM
C.
± Am
bigu
ous
regu
lati
ons,
unva
lidat
ed
draf
t gu
idel
ine
++
SOU
TH 1111± F
or p
ublic
sec
tor
tend
ers;
no
nat
iona
l sys
tem
± Ins
pect
ions
(out
lets
, por
ts
of e
ntry
, pos
t offi
ces
)+ C
ompl
aint
s-ba
sed
only
+* R
epor
ting
to
WH
O-U
MC,
and
ARV
-sp
ecifi
c ce
ntre
(bei
ng s
et u
p at
tim
e of
vis
it)
+ Mon
itor
ed b
y Ad
vert
isin
g St
anda
rds
Auth
orit
y. S
PC n
ot a
vaila
ble
to c
heck
cl
aim
s++
2121−N
o PM
S sy
stem
−Non
e−N
one
− No
lega
l bas
is. N
o ac
tivi
ty, d
raft
gu
idel
ines
− Not
men
tion
ed in
Act
, not
con
trol
led
in p
ract
ice
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p38 80851_Flash-OMS-EMPP.indd 3880851_Flash-OMS-EMPP.indd 38 11/12/10 8:37:06 PM11/12/10 8:37:06 PM
39 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
Regi
onPr
oduc
t qu
alit
y Pr
oduc
t qu
alit
y m
onit
orin
g m
onit
orin
g Q
C te
stin
g of
Q
C te
stin
g of
sa
mpl
essa
mpl
esAn
ti-c
ount
erfe
itin
g An
ti-c
ount
erfe
itin
g pr
ogra
mm
epr
ogra
mm
eN
MRA
pro
ce du
re f
or
NM
RA p
roce
dure
for
ef
fect
ive
reca
llef
fect
ive
reca
ll
Phar
mac
ovig
ilanc
e sy
stem
Ph
arm
acov
igila
nce
syst
em
*=m
embe
r of
WH
O P
rogr
amm
e f.
*=m
embe
r of
WH
O P
rogr
amm
e f.
Int'l
Dru
g M
oni t
orin
g at
tim
e of
vis
it
Int'l
Dru
g M
oni t
orin
g at
tim
e of
vis
it
(htt
p://w
ww
.who
-um
c.or
ght
tp://
ww
w.w
ho-u
mc.
org/
) )
Cont
rol o
f pr
omot
ion
Cont
rol o
f pr
omot
ion
Meds in formation Meds in formation
Coun
try
MID
DLE
0505± I
nspe
ctor
ate
will
in
vest
igat
e co
mpl
aint
sSu
spec
t Su
spec
t sa
mpl
essa
mpl
es−N
one
−Non
e−N
one
−Non
e−−
0808− L
ack
of in
spec
tors
to
cove
r th
e te
rrit
ory
No
(cos
ts)
No
(cos
ts)
± Mul
ti-s
ecto
r pl
an,
nati
onal
aw
aren
ess
day
−No
acti
vity
, dra
ft re
port
ing
form
− Reg
ulat
ions
obs
olet
e, u
nder
re vi
sion
. Co
mm
ittee
not
func
tiona
l−−
1212− N
o re
gula
tion
s, or
gani
zed
by d
istr
ibut
ors
(Impo
r ter
s at
(Im
por t
ers
at
own
cost
) ow
n co
st)
−Non
e−O
nly
by d
istr
ibu t
ors,
not
NM
RA−N
o ac
tivi
ty− W
ith
Min
istr
y of
Art
s. N
o re
gu la
tion
s, no
con
trol
in p
ract
ice
−−
1717− N
o PM
S sy
stem
, few
in
spec
tion
sSu
spic
ious
Su
spic
ious
ca
ses
only
ca
ses
only
−N
one
−Non
e−N
ot e
stab
lishe
d− R
egul
atio
ns e
xist
; sys
tem
not
op
erat
iona
l
2525−N
o PM
S sy
stem
−N
one
−Non
e− N
ot e
stab
lishe
d, d
raft
repo
rtin
g fo
rm
exis
ts− I
nfor
mat
ion
mus
t co
rre s
pond
to
MA;
no
t im
plem
ente
d−−
WES
T 0101± 4
5 su
bsta
nces
mon
itor
ed,
depe
ndin
g on
reso
urce
sLa
b no
t in-
Lab
not i
n-vo
lved
(cos
t)vo
lved
(cos
t)−A
war
enes
s pr
ogra
mm
es−N
o sy
stem
−No
regu
lati
ons,
no c
ontr
ol
1313− Q
C La
bora
tory
can
re
ques
t sa
mpl
es. N
o co
ordi
nate
d st
rate
gy
Mar
ket
con-
Mar
ket
con-
trol
mai
n ta
sktr
ol m
ain
task
− Non
e. P
lans
to
set
up a
na
tion
al c
omm
itte
e −N
one
− Not
est
ablis
hed;
dra
ft re
port
ing
form
. No
link
wit
h sp
ecifi
c di
seas
e pr
ogra
mm
es
− App
rova
l by
Min
Pub
lic H
ealth
(but
no
regu
latio
ns);
prom
otio
n ta
rget
ed a
t m
ed. p
rofe
s sio
nals
free
−−
1414±W
eak
syst
em−N
o of
fi cia
l mea
sure
−Adm
in d
ecis
ion
on
dem
and
of m
anu-
fact
urer
/impo
rter
−No
regi
onal
repo
rtin
g st
ruct
ures
± Pro
mot
iona
l mat
eria
l rev
iew
ed f
or
impo
rt p
erm
its
only
; med
i cal
sam
ples
no
t co
ntro
lled
1818± C
olla
bora
tion
wit
h Q
C la
b; P
MS
syst
em n
ot
com
preh
ensi
ve
In c
ase
of
In c
ase
of
susp
icio
nsu
spic
ion
− Med
ia a
war
enes
s pr
ogra
mm
es±C
ircul
ar le
tter
– n
eeds
m
ore
deta
ils−N
o ac
tivi
ty, d
raft
repo
rtin
g fo
rm−N
o re
gula
tion
s−−
1919+ S
am
ple
s co
llec
ted a
nd
test
ed. La
ck o
f in
spec
tors
for
sam
pling
Yes
Yes
− Gre
y ar
eas,
no c
oher
ent
mea
sure
s
+* N
at. p
harm
aco v
igi la
nce
cent
re,
no li
nk w
ith
NM
RA. R
epor
ting
to
WH
O-U
MC
−Not
ope
rati
onal
2222+ S
am
ple
s ta
ken a
long
dis
trib
uti
on c
hain
(esp
ecia
lly
publ.
sect
or)
QC
test
ing
of
QC
test
ing
of
gene
rics
gene
rics
− No
coor
dina
tion
bet
wee
n N
MRA
, cus
tom
s, po
lice
−Non
e− N
o ac
tivi
ty; 1
sta
ff m
embe
r tr
aine
d.
No
link
wit
h di
seas
e pr
ogra
mm
es
− Min
. Pub
. Hea
lth
on a
dvic
e of
co
mm
itte
e (n
ot s
et u
p). N
o co
ntro
l in
pra
ctic
e −−
2323−N
o PM
S sy
stem
Fo
r na
t. pr
o-Fo
r na
t. pr
o-gr
amm
esgr
amm
es−N
one
±Nee
ds c
larifi
cat
ion
− NM
RA a
ssis
ted
by c
omm
itte
e. V
ery
few
repo
rts,
no a
naly
sis.
Not
link
ed to
ot
her p
rogr
amm
es+C
ontr
ol t
akes
pla
ce−−
2424
± Not
ris
k-ba
sed,
no
guid
elin
es o
r SO
Ps;
NM
RA c
anno
t co
ntro
l en
tire
ter
ritor
y
− No
spec
ifi c
prog
ram
me
(Tas
k Fo
rce
exis
ts)
−Pow
er t
o as
k fo
r re
call,
bu
t no
SO
P
+* N
o le
gal b
asis.
Cen
tre
loca
ted
in N
MRA
. Res
ults
sent
to W
HO
UM
C an
d co
nsid
ered
in re
gula
tory
de
cisio
ns.
−Not
ope
rati
onal
p3980851_Flash-OMS-EMPP.indd 3980851_Flash-OMS-EMPP.indd 39 11/12/10 8:37:10 PM11/12/10 8:37:10 PM
40 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
AN
NE
X 10
: Con
trol
of
clin
ical
tri
als
= u
nder
the
umbr
ella
of t
he N
MRA
; =
ass
ured
by
anot
her b
ody,
= n
o pr
ovis
ion
in re
gula
tory
sys
tem
Coun
try
Auth
o rit
yG
CP/G
LP
requ
ired
Insp
ec ti
ons
Gap
s / r
emar
ks
EAST 02
No
No
One
app
licat
ion
to d
ate
of v
isit
. No
guid
elin
es, n
o te
chni
cal c
omm
itte
e
03N
oN
oN
o co
ntro
l; no
gui
delin
es f
or a
pplic
ants
. Lac
k of
cap
acit
y an
d no
link
s w
ith
exis
ting
eth
ics
com
mit
tees
(who
se ro
le in
con
trol
ling
CT w
as n
ot c
lear
).
04N
atio
nal a
dvis
ory
com
mitt
ee a
ssis
ts w
ith e
thic
al e
valu
atio
n. N
MRA
lack
s ca
paci
ty.
06--
---
-N
o sy
stem
07N
oN
oEt
hica
l ove
rsig
ht b
y N
at. H
ealt
h In
stit
ute.
No
publ
ishe
d gu
idel
ines
on
GCP
/GLP
, sta
ff n
ot t
rain
ed. N
MRA
con
trol
s pr
oduc
t im
port
atio
n.
09N
oN
oAu
thor
izat
ion
by M
oH. N
o im
port
con
trol
or
GM
P fo
r pr
oduc
ts, n
o re
gula
tion
s
10--
---
-N
o sy
stem
15N
oN
oN
MRA
and
Nat
. Eth
ics
Com
mit
tee.
Tw
o Ac
ts, d
uplic
atio
n of
resp
onsi
bilit
ies.
No
regu
lati
ons/
guid
elin
es. I
nsuf
fi cie
nt e
xper
tise
wit
hin
NM
RA: n
o ac
tivi
ty
16N
oN
oN
MRA
on
advi
ce o
f ac
adem
ic re
sear
ch/e
thic
s co
mm
itte
e. N
o re
gula
tion
s or
gui
delin
es; l
ittl
e ex
perie
nce
in N
MRA
, no
coor
dina
tion
of
tria
ls
20N
oCo
ntro
l by
Min
istr
y of
Sci
ence
& T
echn
olog
y, n
o M
emor
andu
m o
f U
nder
stan
ding
, no
regu
lati
ons
26N
oYe
sAp
prox
. 20
appl
icat
ions
/yea
r. Co
ntro
l thr
ough
Cou
ncil
of S
cien
ce a
nd T
echn
olog
y (2
1 co
mm
it te
es);
NM
RA g
rant
s ap
prov
al a
nd c
ontr
ols
prod
uct
impo
rtat
ion.
Gui
delin
es n
ot in
line
wit
h W
HO
-GCP
sta
ndar
ds
SOU
TH 11Ye
s N
o20
0-30
0 ap
plic
atio
ns p
er y
ear.
Appr
oval
by
prof
essi
onal
cou
ncil;
repo
rtin
g of
out
com
es/a
dver
se e
vent
s to
NM
RA.
21N
oN
oRe
spon
sibi
lity
of N
MRA
, but
in p
ract
ice
cont
rolle
d by
a c
omm
itte
e of
whi
ch N
MRA
is a
mem
ber.
No
ethi
cs c
omm
itte
e to
sup
ervi
se c
linic
al t
rials
.
MID
DLE
05--
---
-To
be
intr
oduc
ed w
ith
new
regu
lato
ry s
yste
m
08N
oYe
sCo
ntro
l by
Hea
lth
Rese
arch
Div
isio
n +N
at.E
thic
s Co
mm
itte
e (n
ot fu
nctio
nal).
Res
pons
ibili
ty t
o gr
ant
appr
oval
not
cle
arly
defi
ned
. NM
RA n
ot in
volv
ed
at a
ll
12--
---
-N
o sy
stem
17
No
No
No
acti
vity
for
eth
ical
revi
ew o
r in
spec
tion
, no
GCP
/GLP
regu
lati
ons
or g
uide
lines
, no
GM
P or
impo
rt c
ontr
ol f
or in
vest
igat
iona
l pro
duct
s
25N
oN
oM
oH re
gion
al c
omm
itte
es, n
o ce
ntra
l ove
rsig
ht. D
raft
regu
lati
ons
only
. No
impo
rt c
ontr
ol o
r G
MP
for
inve
stig
atio
nal p
rodu
cts.
WES
T 01N
oN
o of
fi cia
l str
uctu
re, n
o re
gula
tion
s. Co
ntro
l by
Res.
Ethi
cs C
omm
itte
e, o
f w
hich
NM
RA is
not
a m
embe
r. La
ck o
f ca
paci
ty t
o co
ntro
l clin
ical
tria
ls.
13N
oN
oN
eed
appr
oval
by
MoH
on
advi
ce o
f a
rese
arch
com
mit
tee.
Eth
ics
com
mit
tee
exis
ts b
ut h
as n
o ru
les
of f
unct
ioni
ng. N
o co
ntro
l in
prac
tice
.
14N
oN
MRA
con
trol
s on
ly s
tudi
es c
ondu
cted
in c
onne
ctio
n w
ith
appl
icat
ions
for
MA.
Out
date
d re
gula
tion
s
18N
oYe
sEt
hica
l rev
iew
by
com
mit
tee,
app
rova
l by
MoH
, ins
pect
ion
by N
MRA
and
eth
ics
com
mit
tee.
No
impo
rt c
ontr
ol o
r G
MP
for
inve
stig
atio
nal p
rodu
cts.
19Ye
sN
oLe
gal b
asis
exi
sts.
No
form
ally
defi
ned
eth
ics
com
mit
tee
22N
oN
oN
atio
nal E
thic
s Co
mm
itte
e (n
ot f
unct
iona
l). N
o re
gula
tion
s, no
regi
onal
com
mit
tees
; no
cont
rol i
n pr
acti
ce
23N
oN
oN
atio
nal r
esea
rch
com
mit
tee.
No
impo
rt c
ontr
ol o
r G
MP
(incl
. lab
elin
g) f
or in
vest
igat
iona
l pro
duct
s. N
ew d
raft
regu
lati
ons
not
to W
HO
-GCP
st
anda
rds
24Ye
sYe
sG
uida
nce
avai
labl
e fo
r G
CP; G
MP
men
tion
ed b
ut n
ot re
quire
d fo
r lic
ensi
ng o
f in
vest
igat
iona
l pro
duct
s
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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41 As se s s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s
References
(Footnotes)
1 Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Korea, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States.
2 Source of classifi cation into geographic regions: Population Division of the Department of Economic and Social Affairs of the United Nations Secretariat (2009), World Population Prospects: The 2008 Revision, http://unstats.un.org/unsd/methods/m49/m49regin.htm#africa. Sudan as the only country of the North region has been included in the East region.
3 Calculated as: Private expenditure on health as proportion of total expenditure on health × Out-of-Pocket expenditure as proportion of private expenditure on health
4 1933 legislation on the practice of pharmacy remains the basic legislative framework; NMRA was constituted by legislation of 1982.
5 A: Government Department , B: Board/Council/Body corporate, C: parastatal agency.
6 ** = Website introduced after visit [11] *** Website no longer found in 2009
(Endnotes)
1 WHO. Effective medicines regulation: ensuring safety, effi cacy and quality. WHO Policy Perspective on Medicines No. 7. Geneva: WHO, 2003. http://apps.who.int/medicinedocs/pdf/s4921e/s4921e.pdf
2 USP. Matrix of Drug Quality Reports in USAID-assisted Countries. By the U.S. Pharmacopeia Drug Quality and Information Program. July 1st, 2008. Available at www.uspdqi.org
3 Caudron JM, Ford N, Henkens M, Macé C, Kiddle-Monroe R, Pinel J. Substandard Medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health. 2008 Aug;13(8):1062-72. http://www.msf.org.za/docs/Scientifi cDocs/TMIH2008_Vol13_substandards.pdf
4 WHO data collection tool for assessment of regulatory authorities. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/assesment/en/index.html
5 WHO. Practical Guidance for Conducting a Review (based on the WHO Data Collection Tool for the Review of Drug Regulatory Systems). Regulatory Support Series, No.12. Geneva: WHO, 2007. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/assesment/en/index.html
6 WHO. World Health Statistics 2009. http://www.who.int/whosis/whostat/2009/en/index.html
7 WHO. Public-Private Roles in the Pharmaceutical Sector - Implications for Equitable Access and Rational Drug Use - Health Economics and Drugs Series, No. 005. Geneva: WHO, 1997.
8 Ratanawijitrasin S, Wondemagegnehu E. Effective drug regulation: A multicountry study. Geneva: WHO, 2002. apps.who.int/medicinedocs/collect/medicinedocs/pdf/s7916e/s7916e.pdf
9 WHO. Guidelines for registration of fi xed-dose combination medicinal products. Annex 5. In: WHO Technical Report Series No. 929, 2005. http://whqlibdoc.who.int/trs/WHO_TRS_929_eng.pdf
10 WHO. National policy on traditional medicine and regulation of herbal medicines. Report of a WHO global survey. Geneva: World Health Organization, 2005. http://apps.who.int/medicinedocs/collect/medicinedocs/pdf/s7916e/s7916e.pdf
11 WHO. List of Globally identifi ed Websites of Medicines Regulatory Authorities (as of November 2009). http://www.who.int/entity/medicines/areas/quality_safety/regulation_legislation/ListMRAWebsites.pdf
12 WHO. Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: A manual for drug regulatory authorities. Geneva, World Health Organization, 1999 (Regulatory Support Series, No. 5) (WHO/DMP/RGS/98.5). www.who.int/prequal/info_general/documents/WHO_DMP_RGS_98_5_R.pdf
13 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Annex 7. In: WHO Technical Report Series No. 937, 2006. http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf
14 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Guidelines for organizations performing in vivo bioequivalence studies. Annex 9. In: WHO Technical Report Series No. 937, 2006. http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf
p4180851_Flash-OMS-EMPP.indd 4180851_Flash-OMS-EMPP.indd 41 11/12/10 8:37:20 PM11/12/10 8:37:20 PM
42 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s
15 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Guidelines for implementation of the WHO certifi cation scheme on the quality of pharmaceutical products moving in international commerce. Annex 10. In: WHO Technical Report Series No. 863, 1996. Current version of the guideline available at: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certifi cation/en/
16 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Procedure for prequalifi cation of pharmaceutical products. Annex 3. In: WHO Technical Report Series, No. 953, 2009. http://www.who.int/medicines/publications/pharmprep/pdf_trs953.pdf#page=164
17 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Good manufacturing practices for pharmaceutical products: main principles. Annex 4. In: WHO Technical Report Series, No. 908, 2003. whqlibdoc.who.int/trs/WHO_TRS_908.pdf
18 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Guide to good storage practices for pharmaceuticals. Annex 9. In: WHO Technical Report Series No. 908, 2003. whqlibdoc.who.int/trs/WHO_TRS_908.pdf
19 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. WHO good distribution practices for pharmaceutical products. Annex 5. In: WHO Technical Report Series No. 957, 2010. www.who.int/entity/medicines/publications/TRS957_2010.pdf
20 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. WHO good pharmacy practice in community and hospital pharmacy settings. Annex 7. In: WHO Technical Report Series No. 885. Geneva, World Health Organization, 1999.
21 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Quality systems requirements for national good manufacturing practice inspectorates. Annex 8. In: WHO Technical Report Series, No. 902, 2002. http://apps.who.int/prequal/info_general/documents/TRS902/WHO_TRS_902-Annex 8.pdf
22 International Organization for Standardization. ISO/IEC 17025:2005. General requirements for the competence of testing and calibration laboratories. Geneva: ISO, 2005.
23 UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR). Handbook: Good laboratory practice (2nd edition). Quality practices for regulated non-clinical research and development Geneva, 2009. www.who.int/tdr/svc/publications/training-guideline-publications/good-laboratory-practice-handbook
24 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. WHO good practices for pharmaceutical quality control laboratories. Annex 1. In: WHO Technical Report Series No. 957, 2010. www.who.int/tdr/svc/publications/training-guideline-publications/good-laboratory-practice-handbook
25 WHO fact sheet on counterfeiting. Key facts. July 2009. http://www.who.int/medicines/services/counterfeit/CfeitsFactSheetJuly09.pdf
26 World Medical Association. Declaration Of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, as amended by the 59th WMA General Assembly, Seoul, October 2008. http://www.wma.net/en/30publications/10policies/b3/index.html
27 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Annex 3. In: WHO Technical Report Series No. 850, 1995. http://www.who.int/medicinedocs/collect/medicinedocs/pdf/whozip13e/whozip13e.pdf
28 OMS, Comité Régional de l’Afrique. Cinquante-sixième session, Addis-Abéba, Ethiopie, 28 août – 1er septembre 2006. Autorités de réglementation pharmaceutique: situation actuelle et perspectives. Rapport du Directeur régional. www.afro.who.int/rc56/documents/french/afr_rc56_11_autorites_reglement_pharmaceutique.pdf
29 FIP. 2009 FIP Global Pharmacy Workforce Report. www.fi p.org/www/index.php?page=menu_resourcesforhealth
30 South African Health Review 2003/04. Chapter 22: Human resources. Durban: Health Systems Trust, 2004.
31 Conférence Internationale des Ordres de Pharmaciens Francophones (CIOPF). Fiches des pays. http://www.ciopf.org/fi ches_des_pays/
32 Medicine Prices in Ghana: A comparative study of Public, Private and Mission sector medicine prices. Accra: Ghana Health Service, Ministry of Health, 2006.
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
p42 80851_Flash-OMS-EMPP.indd 4280851_Flash-OMS-EMPP.indd 42 11/12/10 8:37:25 PM11/12/10 8:37:25 PM
80851_Flash-OMS-EMPP.indd 4380851_Flash-OMS-EMPP.indd 43 11/15/10 6:03:59 PM11/15/10 6:03:59 PM
Job no: 80851 Title: Assessment of Medicing Client: 12648Scn: #175Size: 210(w)297(h)mm Co: M11Dept: DTP D/O: 13.11.10(Job no: 000000 D/O: 00.09.10 Co: CM11)
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