DRUG REGULATORY AFFAIRS
The Backbone of pharmaceutical industry
Presented by: Iram Naila
Feb 28, 2015
Drug Regulatory Affairs
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Regulatory Affairs
Key Players involved..
Drug Regulatory
Authority
Pharmaceutical
Industry
Regulatory Affairs
Professionals
Bridging the gap...
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Objectives
Create awareness,
– Role of Drug Regulatory Affairs department in
the progress of pharmaceutical industry
– Responsibilities of Pharmaceutical Regulatory
Affairs Professionals
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
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)
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The Pharmaceutical Industry has
Mediated the Opposite Forces
Economic
Factors
Pharmaceutical
Industry
Scientific
Innovation
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
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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
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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?
Based on which criteria?
(quality, inspection)
(objective and subjective)
Based on which criteria?
By whom?
(objective and subjective))
(the authority)
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Regulatory Affairs
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Court Room Scenario..
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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
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Regulatory Affairs
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Regulations…
Our life is
“regulated”
in many different ways
continuously…
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Hierarchy of the Rules…
Hard
law
Professional
rules
(soft law)
Ethical rules
Custom, fashion, common
courtesy
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Hierarchy of the
most important professional rules
+
HIERARCHI
Hard law
Soft law
Constitution
Acts of Parliament
Government laws
Rules framed under Govt. laws
Guidelines
methodological letters of
National Boards/Institutes
Scientific literature
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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
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!
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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
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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
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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.
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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
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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Drug Regulatory Authority of
Pakistan- DRAP
13 Division
Headed by
Directors
Boards &
Committees
DRAP
Policy Board
(Headed by
CEO)

Expert
Committees
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
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Pharmaceutical Licensing
Receipt of
proposal
Site
verification by
inspection
Deficiency:
•Approval suspended
•Reapplication after 3-6
months
Rejection of application
Approval of Layout
(Central Licensing Board/Committee_
Formal application after
site approval
Panel Inspection
Report to CLB
(Central Licensing Board)
Approval and grant of
license
Marketing Authorization
Submission
Registration
application
Dossier
evaluation
(Evaluation
Cell)
Dossier
complete
Inform
company for
completion of
dossier
Drug
Registration
Board
New
Molecule
Reject
Negative
E.Op
Expert
Evaluation
Me Too
product
Reject
Positive
Expert
opinion
Approved
Appellate
Board
Price
Fixation
(DPC)
Reg Cert.
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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.
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ICH
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)
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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
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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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The RA professionalsRoles 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
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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
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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
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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
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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 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.
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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…
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