DRUG REGULATORY AFFAIRSDRUG REGULATORY AFFAIRSThe 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
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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 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 Pharmaceutical LicensingLicensing
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 Marketing AuthorizationAuthorization
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 forUse 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…
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