DRUG REGULATORY AFFAIRSDRUG REGULATORY AFFAIRS

The Backbone of pharmaceutical industryThe Backbone of pharmaceutical industry

Presented by: Iram Naila Feb 28, 2015

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Drug Regulatory AffairsDrug Regulatory Affairs

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Regulatory Affairs

Pharmaceutical Industry

Drug Regulatory Authority

Regulatory Affairs Professionals

Bridging the gap...Bridging the gap...

Key Players involved..

ObjectivesObjectives

Create awareness,Create awareness,

– Role of Drug Regulatory Affairs department in Role of Drug Regulatory Affairs department in

the progress of pharmaceutical industrythe progress of pharmaceutical industry

– Responsibilities of Pharmaceutical Regulatory Responsibilities of Pharmaceutical Regulatory

Affairs ProfessionalsAffairs Professionals

Nature of Pharmaceutical Industry

Pharmaceutical Regulatory Affairs

Global Drug Regulatory Bodies

Drug Regulatory Authority of Pakistan

Drug Regulation in Pakistan

Regulatory procedures in Pakistan

Pharma Regulatory Professionals

Global Pharma Regulatory Professional Associations

Scope

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Pharmaceutical Industry-ATTRIBUTES

Fast Growing market

Highly Regulated industry

Ever changing regulations

Increased globalization

High competitiveness

Highly dependent on science & technology

Costly R&D, Innovation, Invention

Stringent Quality standards

Development of new therapeutic fields & technologies

Quick development of the world generic markets

Increased importance of strategic management

Increased importance of regulatory issues (registrations, intellectual property)

The Pharmaceutical Industry has The Pharmaceutical Industry has Mediated the Mediated the Opposite Forces Forces

Pharmaceutical Pharmaceutical IndustryIndustry

Scientific Innovation

Economic Factors

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The key to success lies in The key to success lies in driving the driving the Research and Research and Development (R&D)Development (R&D) efforts of efforts of the company to the market in the company to the market in the the least possibleleast possible timetime & & expenseexpense with a with a commercially viable labelviable label

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• Identification & Compliance of Regulatory Requirements

• Strategic guidance & technical advice to R&D, Production, QC dept of the company

• Regulatory submissions and approvals

• Keep record of ever-changing legislation

Role of RA

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Any activity with DRUG..

By whom?

(the authority)

Does not belong to drug regulatory affairs

Yes

Prior authorisation/submission

needed?

Based on which criteria?

(objective and subjective)

Subject to regular control?

(quality, inspection)

By whom?

(the authority)

Based on which criteria?

(objective and subjective))

NO

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Regulatory Affairs

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Court Room Scenario..

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Communication Gap Communication Gap

•Inadequate reporting of data… hamper timely & positive evaluation of registration application.

•Even worse, release of product bearing incorrect labeling … product recall.

• Loss of sales, image of the product, Brand equity

For example;For example;

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Regulatory Affairs Regulatory Affairs

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Regulations…

Our life is

“regulated” in many different ways

continuously…

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Ethical rules

Professional rules

(soft law)

Hard law

Custom, fashion, common courtesy

Hierarchy of the Rules…

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Hierarchy of the most important professional rules

Hard law

Soft law

Constitution

Acts of Parliament

Government laws

Rules framed under Govt. laws

Guidelines

methodological letters of

National Boards/Institutes

Scientific literature

+

-

HIE

RA

RC

HI

2020

Almost Everybody knows about Cricket game in Pakistan

Imagine a very good cricketer…

His only problem is that he does not know

the rules e.g. “No Ball”, “LBW”, etc.

your opinion…. can he be successful as a

team member?

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The same is valid for The same is valid for Drug Regulatory Affairs! Drug Regulatory Affairs!

MMore than simplore than simplyy ““administration”!administration”!

The Art of Pharmacy belongs to the The Art of Pharmacy belongs to the Regulated FieldRegulated Field! !

Thus, toThus, to know the relevant regulations is the know the relevant regulations is the

professional life itself!professional life itself!

The problem is: The problem is: wewe can not simply learn it, Instead, can not simply learn it, Instead, wewe

must understand the must understand the logiclogic behind it behind it!!

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Drug Law in PakistanDrug Law in Pakistan

Law maker: Parliament, Govt. of Pakistan

Implementation of Law: – Drug Regulatory Authority of Pakistan (DRAP)

Execution of Drug Laws:

– Pharmaceutical companies– Pharmacies– Regulators

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• Drug Regulatory Authority of Pakistan (DRAP) Act 2012Drug Regulatory Authority of Pakistan (DRAP) Act 2012

• Drugs Act 1976Drugs Act 1976

• The Drugs (Labeling and Packaging) Rules 1986The Drugs (Labeling and Packaging) Rules 1986

• The Drugs (Licensing, Registration and Advertisement) The Drugs (Licensing, Registration and Advertisement) Rules 1976Rules 1976

• The Drugs (Appellate) Rules 1976The Drugs (Appellate) Rules 1976

• The Drugs (Research) Rules 1978The Drugs (Research) Rules 1978

• The Drugs (Federal Inspector, Federal Drug Laboratory & Federal The Drugs (Federal Inspector, Federal Drug Laboratory & Federal Government Analyst) Rules 1976 Government Analyst) Rules 1976

• The Drugs (Import & Export) Rules 1976The Drugs (Import & Export) Rules 1976

• The Drugs (Specification) Rules 1978The Drugs (Specification) Rules 1978

Drug Law in PakistanDrug Law in Pakistan

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Extends to whole Pakistan

Establishment of DRAP

Policy Board

Change in definition of drug.

Some new definitions i.e. Therapeutic goods, Medical Device, Alternative medicine, Health & OTC Products.

Control of Non pharma drugs

Power of Federal Govt. to make rules

Power of provincial Govt. to make rules

Refers to Drugs Act for regulatory procedures & approvals…Drugs Act 1976 is still there.

DRAP ACT 2012

It extends to the whole of Pakistan

Regulates drug Import, Export, Manufacture,

Storage, Distribution and Sale

Registration of drugs under this Act would not

constitute defense against infringement

regulated by Patent and Design Act 1911.

Application of other laws not barred

Drugs Act 1976

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Drugs Act 1976

Composition:

Preamble and Scope

Definitions

Administration and Enforcement

Prohibition

Offence, Penalties and Procedure

Power of Federal Govt. to make rules

Power of provincial Govt. to make rules

Repeal and Savings

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Drug Regulatory Authority of Pakistan- DRAP

Established under the DRAP Act 2012 

Concerned Ministry; National Health Services & Regional Coordination

Aims & Objectives

– To provide effective coordination and enforcement of Drugs Act, 1976 for provision of drugs and therapeutic goods that are safe, effective, quality and economical.

– To bring harmony in interprovincial trade and commerce of drugs and therapeutic goods

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Boards & Committees

Expert Committees

Policy Board

13 DivisionHeaded by Directors

DRAP(Headed by

CEO)

Drug Regulatory Authority of Drug Regulatory Authority of Pakistan- DRAP Pakistan- DRAP

Policy Board of DRAP: - Policies and guidelines - implementation of the guidelines- Functions of functions of DRAP- approve budget of DRAP- Determine all fees and levies

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DRAP-Responsibilities

Regulatory Approvals

– Registration & Post Registration Variations of pharmaceutical drugs, Biologicals, Medical Devices, Health Products, Alternative Medicine.

– Licensing of Drug Manufacturing units, Biological Manufacturing facilities, Alternative Medicine manufacturing facilities

– Pricing of products

Quality Control function

Pharmacovigilance

Guideline: cGMP Guidelines, Guidelines for Enlistment and Registration of Alternative Medicines, Guidelines for Licensing of Pharmaceutical Units.

Policies

– Contract Manufacturing Policy

– Import Policy

– Pricing Policy

Pharmaceutical LicensingPharmaceutical Licensing

Receipt of proposal

Site verification by inspection

Approval of Layout

(Central Licensing Board/Committee_

Formal application after site approval

Panel Inspection

Report to CLB

(Central Licensing Board)

Deficiency:

•Approval suspended

•Reapplication after 3-6 months

Rejection of application

Approval and grant of license

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Marketing AuthorizationMarketing Authorization

Submission Registration application

Dossier evaluation (Evaluation Cell)

Dossier complete

Me Too product

RejectAppellate Board

Inform company for completion of dossier

New Molecule

Positive Expert opinion

Approved

RejectNegative E.Op

Expert Evaluation

Price Fixation(DPC)

Reg Cert.

Drug Registration Board

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USA : Food and Drug Administration (FDA)

Europe: European Medicines Agency (EMA)

Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

UK: Medicine and Healthcare Products Regulatory Agency (MHRA)

Australia: Therapeutic Goods Administration (TGA)

Historically, the various regulatory authorities have had their own regulatory procedures…..Inconvenience & High Cost

International Conference on Harmonization (ICH) is an attempt to co-ordinate and synthesize international regulatory requirements.

Global Drugs Regulatory Bodies

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Members (Steering Committee

1. US Food and Drugs Administration (FDA)

2. Pharmaceutical Research and Manufacturers of America (PhRMA)

3. European Medicine Agency (EMA)

4. European Federation of Pharmaceutical Industries Associations (EFPIA)

5. Japan Ministry of Health, Labour, and Welfare (MHLW )

6. Japan Pharmaceutical Manufacturers Association – JPMA

International Federation of Pharmaceuticals Manufacturers (IFPMA)

Observers:

1. Health Canada

2. WHO

3. European Fair Trade Association (EFTA)

ICH

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Q: "Quality" Topics, i.e., Chemical and pharmaceutical

Quality Assurance (Stability Testing, Impurity Testing, etc.)

S: "Safety" Topics, i.e., those relating to in vitro and in

vivo pre-clinical studies (Carcinogenicity Testing etc.)

E: "Efficacy" Topics, i.e., those relating to clinical studies

in human subject (Dose Response Studies, Good Clinical Practices, etc.)

 M: "Multidisciplinary" Topics, i.e., cross-cutting Topics

which do not fit uniquely into one of the above categories

ICH Guidelines

For details: www.ich.org

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• Regulatory professional is central to the business

• Relate to almost every discipline within the industry

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Associations of Pharma RA

US: Regulatory Affairs Professional Society (RAPS)

UK: The Organization of Pharmaceutical Regulatory Affairs

Canada: Canadian Association of Professionals in Regulatory Affairs

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The RA professionals-Roles and Responsibilities

Role starts from research and development phases

moving into clinical trials

extending through premarket approvals

manufacturing

labeling and advertising

Post marketing Surveillance

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Responsible for

Use and assimilate information provided by all departments

present that information to regulatory authorities i.e. for registration, licensing and other approvals

feed back their opinions to the rest of the company

Subsequent negotiations to obtain and maintain Regulatory approvals

Regulatory Intelligence

Strategic and technical advice at the highest level ….. an important contribution both commercially and scientifically to the success of a development programme

Ensure Regulatory Compliance for company’s products

The RA professionals-Roles and Responsibilities

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Understanding of Pharmaceutical sector

knowledge of regulations.

Tracking of regulatory changes and interpretation the implications of the regulations to the organization.

Knowledge and application of regulatory approval procedures:

Good Manufacturing Practice (GMP)

Knowledge and application of Pharmacovigilance

Knowledge about emerging technologies

As they move up the career ladder …

– business skills (finance, marketing, policy, etc.)

– Ability to integrate their regulatory knowledge into business strategy and decision making

Key Regulatory Competencies

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Soft Skills:

Time management

Marketing for regulators

Negotiation and influencing skills

Presentation skills

strategic thinking

Leadership skills

Team work in a global environment

Project management

Crisis management

Key Regulatory Competencies

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‘Right first time’ approach

Scientifically accurate and knowledgeable …. Better response from regulators.

The ability to tackle data in a wide range of scientific areas.

Quickly grasp new concepts and complex technical information.

Understanding of legal & scientific matters and Attention to detail.

An analytical frame of mind: Ability to evaluate the strengths and weaknesses of the technical and legal options open to a company

They are strategic thinker

Integrity and the ability to inspire trust and confidence

How to be a good regulatory How to be a good regulatory professionalprofessional??

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Canvas of RA

Regulatory professionals are employed in industry, government and academia

Involved with a wide range of products

– pharmaceuticals

– medical devices

– in vitro diagnostics

– biologics and biotechnology

– nutritional products

– cosmetics

– veterinary products

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Who is eligibleWho is eligible

Regulatory professionals come from diverse backgroundsRegulatory professionals come from diverse backgrounds

Graduates in a scientific discipline – particularly pharmacy, or may be other life sciences

TOPRA offers an MSc in Regulatory Affairs

experience is a key asset for regulatory professionalsexperience is a key asset for regulatory professionals

Usually have experience in other careers before transitioning into Usually have experience in other careers before transitioning into regulatory affairs. regulatory affairs.

The candidates that moved straight into Regulatory Affairs from The candidates that moved straight into Regulatory Affairs from university often moved to small to mid size pharmaceutical, generic university often moved to small to mid size pharmaceutical, generic and device based companies.and device based companies.

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RA - the best things about

Challenging and dynamic field.

combines knowledge and skills from many different fields

Guardian of the image & integrity of the organization they work for.

Resistant to industry downsizing

RA professionals are in demand, and the demand is increasing.

Senior professionals are increasingly being appointed to Boardroom positions, where they can advise upon and further influence the strategic decisions of their companies.

It’s the work you can really be proud of.

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O.K., let us change the topic now…O.K., let us change the topic now…