1. DRUG REGULATORY AFFAIRS
The Backbone of pharmaceutical industry
Presented by: Iram Naila
Feb 28, 2015

2. Drug Regulatory Affairs

3. Regulatory Affairs Key Players involved.. Bridging the gap...
Drug Regulatory Authority
Pharmaceutical Industry
Regulatory Affairs Professionals
Bridging the gap...

4. Objectives Create awareness,
Role of Drug Regulatory Affairs department in the progress of pharmaceutical industry
Responsibilities of Pharmaceutical Regulatory Affairs Professionals

5. 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

6. 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)

7. The Pharmaceutical Industry has Mediated the Opposite Forces
Economic Factors
Pharmaceutical Industry
Scientific Innovation

8. 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

10. Any activity with DRUG.. Prior authorisation/submission needed? NO
Does not belong to drug regulatory affairs
Yes
By whom?
(the authority)
Subject to regular control?
(quality, inspection)
Based on which criteria?
(objective and subjective)
By whom?
(the authority)
Based on which criteria?
(objective and subjective))

11. Regulatory Affairs

12. Court Room Scenario..

15. Communication Gap
For example;
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

16. Regulatory Affairs

17. Regulations… “regulated” Our life is in many different ways
continuously…

18. Hierarchy of the Rules… Custom, fashion, common courtesy
Hard law
Professional rules
(soft law)
Ethical rules
Custom, fashion, common courtesy 18

19. 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
HIERARCHI -

20. 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?

21. The same is valid for Drug Regulatory Affairs!
More than simply “administration”!
The Art of Pharmacy belongs to the Regulated Field!
Thus, to know the relevant regulations is the professional life itself!
The problem is: we can not simply learn it, Instead, we must understand the logic behind it!

22. Drug 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

23. 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

24. DRAP ACT 2012 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.

25. Drugs Act 1976 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

26. 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

27. 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

28. Drug Regulatory Authority of 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

29. 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

30. Pharmaceutical Licensing
Site verification by inspection
Receipt of proposal
Approval of Layout
(Central Licensing Board/Committee_
Deficiency:
Approval suspended
Reapplication after 3-6 months
Formal application after site approval
Panel Inspection
Report to CLB
(Central Licensing Board)
Rejection of application
Approval and grant of license

31. Marketing Authorization
Submission
Registration
application
Dossier
evaluation
(Evaluation
Cell)
complete
Me Too
product
Reject
Appellate
Board
Inform
company for
completion of
dossier
New
Molecule
Positive
Expert
opinion
Approved
Negative
E.Op
Evaluation
Price
Fixation
(DPC)
Reg Cert.
Drug

32. Global Drugs Regulatory Bodies
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.

33. ICH Members (Steering Committee
US Food and Drugs Administration (FDA)
Pharmaceutical Research and Manufacturers of America (PhRMA)
European Medicine Agency (EMA)
European Federation of Pharmaceutical Industries Associations (EFPIA)
Japan Ministry of Health, Labour, and Welfare (MHLW )
Japan Pharmaceutical Manufacturers Association – JPMA
International Federation of Pharmaceuticals Manufacturers (IFPMA)
Observers:
Health Canada
WHO
European Fair Trade Association (EFTA)

34. ICH Guidelines
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
For details:

35. Regulatory Affairs Professionals

36. Regulatory professional is central to the business
Relate to almost every discipline within the industry

37. 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

38. 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

39. The RA professionals- Roles and Responsibilities
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

40. Key Regulatory Competencies
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

41. Key Regulatory Competencies
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

42. How to be a good regulatory professional?
‘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

43. 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

44. Who is eligible Regulatory 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 professionals
Usually have experience in other careers before transitioning into regulatory affairs.
The candidates that moved straight into Regulatory Affairs from university often moved to small to mid size pharmaceutical, generic and device based companies.

45. 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.

46. O.K., let us change the topic now…46