Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals

1. Presented by Aneela Saleem
Presented to Dr. Idress

2. CONTENTS
• Introduction
• Objectives
• Scope
• Pharmaceutical Industry-attributes
• Role of RA
• Drug Law in Pakistan
• Drug Regulatory Authority of Pakistan- DRAP
• Major Drug Regulatory Authorities
• Qualities of a good RA professional
• Canvas of RA
• Conclusion
• References

3. INTRODUCTION
 Regulatory Affairs (RA), also called Government Affairs, is a
profession within regulated industries, such as
 pharmaceuticals
 medical devices
 Energy
 banking.
 Regulatory Affairs also has a very specific meaning within the
healthcare industries (pharmaceuticals, medical devices,
Biologics and functional foods) most companies, whether they
are major multinational pharmaceutical corporations or small,
innovative biotechnology companies, have specialist
departments of Regulatory Affairs professionals

4.  The regulatory authority of a country approves the
drug for marketing only if the drug is safe
 effective for human use or the drug has more
benefits than its adverse effects

5. OBJECTIVES
 Create awareness,
 Role of Drug Regulatory Affairs department in the
progress of pharmaceutical industry
 Responsibilities of Pharmaceutical Regulatory
Affairs Professionals

6. SCOPE
 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

7. PHARMACEUTICAL INDUSTRY-
ATTRIBUTES
 Fast Growing market
 Highly Regulated industry
 Ever changing regulations
 Increased globalization
 High competitiveness
 Highly dependent on science & technology
 Costly Research & Development, 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)

8. THE PHARMACEUTICAL INDUSTRY HAS MEDIATED THE
OPPOSITE FORCES
 The key to success lies in driving the
Research and Development (R&D)
efforts of the company to the market
in the least possible time & expense
with a commercially viable label

9. ROLE OF RA
 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

11. REGULATORY AFFAIRS DEALINGS

12. DRUG LAW IN PAKISTAN
 Law maker: Parliament, Govt. of Pakistan
 Implementation of Law:
• Drug Regulatory Authority of Pakistan
(DRAP)
o Execution of Drug Laws:
• Pharmaceutical companies
• Pharmacies
• Regulators

13. DRUG REGULATORY AUTHORITY OF
PAKISTAN- DRAP
 Established under the DRAP Act 2012
 Concerned Ministry; National Heal 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

14. DRUG LAW IN PAKISTAN
 Drug Regulatory Authority of Pakistan (DRAP) Act 2012
 Drugs Act 1976
 The Drugs (Labeling and Packaging) Rules 1986
 The Drugs (Licensing, Registration and Advertisement)
Rules 1976
 The Drugs (Appellate) Rules 1976
 The Drugs (Research) Rules 1978
 The Drugs (Federal Inspector, Federal Drug Laboratory
& Federal Government Analyst) Rules 1976
 The Drugs (Import & Export) Rules 1976
 The Drugs (Specification) Rules 1978

15. DRUG REGULATORY AUTHORITY OF
PAKISTAN- DRAP
Boards &
Committees
Expert
Committees
Policy Board
13 Division
Headed by
Directors
DRAP
(Headed by
CEO)
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

16. 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

18. MAJOR DRUG REGULATORY AUTHORITIES
Country Regulatory Authority
India
Central Drugs Standard Control Organization
Drug controller general of India (DCGI)
US Food and Drug Administration (US FDA)
UK
Medicines and Health care products regulatory
Agency (MHRA)
Australia Therapeutic Goods Administration (TGA)
Japan
Japanese Ministry of health, Labour and Welfare
(MHLW)
Canada Health Canada
Brazil
Agency Nacional degradation Vigilancia Sanitaria
(ANVISA)
South Africa Medicines Contol Council (MCC)
Europe
European Directorate for Quality of Medicines
(EDQM)
European Medicines Evaluation agencies (EMEA)
Country Regulatory Authority
India
Central Drugs Standard Control Organization
Drug controller general of India (DCGI)
US Food and Drug Administration (US FDA)
UK
Medicines and Health care products regulatory Agency
(MHRA)
Australia Therapeutic Goods Administration (TGA)
Japan Japanese Ministry of health, Labour and Welfare (MHLW)
Canada Health Canada
Brazil Agency Nacional degradation Vigilancia Sanitaria (ANVISA)
South Africa Medicines Contol Council (MCC)
Europe European Directorate for Quality of Medicines (EDQM)
European Medicines Evaluation agencies (EMEA)

19. QUALITIES OF A GOOD RA PROFESSIONAL
 Authoritative
 Team Player
 Decisive
 resourceful
 Good Communication Skill
 Analytical skills.
 Good Informational Technology skills
 Negotiating Skills
 Able to reapply scientific and regulatory principles
 Ability to work with other disciplines
 Flexible- Always willing to learn.

20. 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

21. CONCLUSION
 Regulatory Affairs departments are growing within
companies. Due to the changing resources
necessary to fulfill the regulatory requirements,
some companies also choose to outsource or out
task regulatory affairs to external service providers.
 In today’s competitive environment the reduction of
the time taken to reach the market is critical to a
product’s and hence the company’s success. The
proper conduct of its Regulatory Affairs activities is
therefore of considerable economic importance for
the company.

22. REFRENCES
 International regulatory affair updates, 2005. available at
http,//www.iraup.com/about.php
 Regulatory Affairs brought by learning plus, inc. available at
http,//www.cgmp.com/ra.htm
 Ng R. Drugs: from discovery to approval 2004.
http://www.pharmatext.org/2008/06/drugs-from-discovery-to-
approval.html 7
 en.wikipedia.org/wiki/Regulatory_affairs (Dec 2011)
 topra.org/careers/what-regulatory-affairs (Jan 2012)

23. THANK YOU