DRUG REGULATORY AFFAIRS

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..
Pharmaceutical Industry
Drug Regulatory Authority
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 RD, 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 (RD) 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 RD,
  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..
13
(No Transcript)
14
(No Transcript)
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
Our life is regulated in many different ways
continuously
18
Hierarchy of the Rules
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
  approvalsDrugs 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_
Formal application after site approval

• Deficiency
• Approval suspended
• Reapplication after 3-6 months

Panel Inspection Report to CLB (Central Licensing
Board)
Rejection of application
Approval and grant of license
31
Marketing Authorization
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..Inconve
  nience 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 www.ich.org
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 companys
  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.
• Its the work you can really be proud of.

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