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Introduction to Regulatory Affairs & Good Regulatory
Practices
Rashid Mureed
Definition
 A regulatory affair (RA) is a profession which acts as the interface
between pharmaceutical industry and drug regulatory authorities
across the world.
 Regulatory Affairs is actively involved in every stage of
development of a new medicine and in the post-marketing activities
with authorised medicinal products
 RA has very specific meaning to healthcare sectors
(Pharmaceutical, medical device, HOTC and Biotechnology
22 February 2020
2
Introduction to Regulatory Affairs
Introduction
22 February 2020
3
Introduction to Regulatory Affairs
 Production Department
 Quality Control Department
 Warehouse Department
 Finance Department
 Marketing Department
22 February 2020
4
Introduction to Regulatory Affairs
Old Concept
 Production Department
 Quality Control Department
 Finance Department
 Marketing Department
 Regulatory Affairs Department
 Medical Affairs Department
 Business Development Department
 Supply Chain Department(W/H part of it)
 Engineering Department
 Quality Assurance Department
 Quality Compliance Department
 NPD & R & D Department
 HR Department
 IT Department
22 February 2020
5
Introduction to Regulatory Affairs
Current Practices
 Pakistan Pharmaceutical Drugs Laws
 CTD/eCTD Dossier
 DMF/ANDA/NDA
 Bioequivalence Studies
 Basic GMP Documentations
22 February 2020
6
Introduction to Regulatory Affairs
Basic Understanding on
Guidelines
 Liaison with Health authorities
 Regulatory Compliance
 Keep focus on current & changing regulations
 Registration documents to health authorities
 To give strategic directions to technical departments
 Provide right solution of the technical problems under the light of
current regulations
 Manage Product Life Cycle
 Facilitate Regulators in timely arranging & sharing the documents
 Lead Facility Inspections
 To assist in regulars audits
22 February 2020
7
Introduction to Regulatory Affairs
Roles & Responsibilities of RA
Professionals
Goals of Regulatory
Professionals
22 February 2020Introduction to Regulatory Affairs
 Protection of Human health
 Ensuring the safety, efficacy and safety of Drugs
 Ensuring the product information
8
Medicines is a very special category of products „Consumers, patients and (even)
health care workers have limited capacity to judge there:
S A F E T Y
Q U A L I T Y
E F F I C A C Y „
And all these have to built in ONE – the medicine
Introduction to Regulatory AffairsSaturday, February 22, 2020
9
Regulators Perception
 Pharma industries and their products likely the most regulated industries/products, but …
perhaps aircraft industry regulations have achieved globally better results
 Most journeys by air from A to B are very effective and safe (very high % starting the
journey reaches from A to B, almost all getting in air land safely as well) „
 If the aircraft business would be globally regulated as good or bad as medicines today
 Perhaps quite high % of planes would not take off the ground or would not reach the
destination for quality reasons
 Not talk about the inherent relative lack of efficacy of many medicines
In case of medicines it is not rare that from 100 persons starting the journey (treatment) only
less than 10 may reach the destination (cure)
Introduction to Regulatory AffairsSaturday, February 22, 2020
10
How medicines industry regulation compares
with other well regulated industries?
Regulatory Functions
22 February 2020Introduction to Regulatory Affairs
11
Regulatory Marketing
Authorization
22 February 2020Introduction to Regulatory Affairs
12
Patent cliffs
Exploding costs of drug discovery and development
Much higher hurdles for approval for major indications
Blockbuster strategy is dead
Niche markets
Orphan indications
High failure rate – have to cover cost of failures in pricing of successful drugs
Generic competition
Big Pharma moving more toward Development and away from Discovery
Introduction to Regulatory AffairsSaturday, February 22, 2020
13
Emerging Issues and
challenges
Scientific
Regulatory
Marketing
Legal
Healthcare
Professional
Patient
Introduction to Regulatory AffairsSaturday, February 22, 2020
14
Emerging Issues and
challenges
Introduction to Regulatory Affairs 22 February 2020
15
Emerging Issues and
challenges
 From elementary quality requirements to safety and efficacy
 From quality control of finished product to quality of manufacturing
 From quality control of finished products and inspection of manufacturing
sites in general to more understanding the processes and product specific
process involved.
 From rigid limits to agreed upon before hand set of limits which can be
used by manufacturer in a more flexible manner
Introduction to Regulatory Affairs 22 February 2020
16
Shifting Regulatory Paradigm
Paradigm
Increased role of
science –new
molecules, new
advance
therapies and
combination of
advance
therapies
(Medicine +MD)
Paradigm
From national to
international- not
a single regulator
today work
meaningfully in
isolation and not
using other
regulators
Paradigm
Increasing need
to decide what
regulatory
functions
priorities
nationally and
what expertise
/capabilities to
build
Introduction to Regulatory AffairsSaturday, February 22, 2020
17
Shifting Regulatory Paradigm
Good Regulatory Practices
Introduction to Regulatory Affairs
18
Principles of
good regulatory
practices
Implementing
good regulatory
practices
22 February 2020
Principles of good regulatory
practices
22 February 2020Introduction to Regulatory Affairs
 Legality: Regulation should have a sound legal basis and
should be consistent with existing legislation, including
international norms or agreements.
 Impartiality: Regulation and regulatory decisions should be
impartial in order to be fair and to avoid conflicts of interest,
unfounded bias or improper influence from stakeholders.
 Consistency: Regulations should be clear and predictable;
both the regulator and the regulated party should understand
the behavior and the conduct that are expected and the
consequences of noncompliance.
 Proportionality: Regulations and regulatory decisions should
be proportional to the risk and should not exceed what is
necessary to achieve the objectives.
19
22 February 2020Introduction to Regulatory Affairs
 Flexibility: Regulations should not be prescriptive; they should
allow flexibility in responding to a changing regulated
environment and different or unforeseen circumstances.
 Effectiveness: Regulations should produce the intended
result.
 Efficiency: Regulations should achieve their goals within the
required time, effort and cost.
 Clarity: Regulations should be accessible to, and understood
by, the users;
 Transparency: Regulatory systems should be transparent;
requirements and decisions should be made known to
affected parties and, where appropriate, to the public in
general.
20
Principles of good regulatory
practices
Implementing good regulatory
practices
22 February 2020Introduction to Regulatory Affairs
21
 GRP in the pharmaceutical industry
 Quality assurance in the pharmaceutical
industry
22 February 2020Introduction to Regulatory Affairs
22

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Description & functions of drug regulatory affairs

  • 1. Introduction to Regulatory Affairs & Good Regulatory Practices Rashid Mureed
  • 2. Definition  A regulatory affair (RA) is a profession which acts as the interface between pharmaceutical industry and drug regulatory authorities across the world.  Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products  RA has very specific meaning to healthcare sectors (Pharmaceutical, medical device, HOTC and Biotechnology 22 February 2020 2 Introduction to Regulatory Affairs
  • 4.  Production Department  Quality Control Department  Warehouse Department  Finance Department  Marketing Department 22 February 2020 4 Introduction to Regulatory Affairs Old Concept
  • 5.  Production Department  Quality Control Department  Finance Department  Marketing Department  Regulatory Affairs Department  Medical Affairs Department  Business Development Department  Supply Chain Department(W/H part of it)  Engineering Department  Quality Assurance Department  Quality Compliance Department  NPD & R & D Department  HR Department  IT Department 22 February 2020 5 Introduction to Regulatory Affairs Current Practices
  • 6.  Pakistan Pharmaceutical Drugs Laws  CTD/eCTD Dossier  DMF/ANDA/NDA  Bioequivalence Studies  Basic GMP Documentations 22 February 2020 6 Introduction to Regulatory Affairs Basic Understanding on Guidelines
  • 7.  Liaison with Health authorities  Regulatory Compliance  Keep focus on current & changing regulations  Registration documents to health authorities  To give strategic directions to technical departments  Provide right solution of the technical problems under the light of current regulations  Manage Product Life Cycle  Facilitate Regulators in timely arranging & sharing the documents  Lead Facility Inspections  To assist in regulars audits 22 February 2020 7 Introduction to Regulatory Affairs Roles & Responsibilities of RA Professionals
  • 8. Goals of Regulatory Professionals 22 February 2020Introduction to Regulatory Affairs  Protection of Human health  Ensuring the safety, efficacy and safety of Drugs  Ensuring the product information 8
  • 9. Medicines is a very special category of products „Consumers, patients and (even) health care workers have limited capacity to judge there: S A F E T Y Q U A L I T Y E F F I C A C Y „ And all these have to built in ONE – the medicine Introduction to Regulatory AffairsSaturday, February 22, 2020 9 Regulators Perception
  • 10.  Pharma industries and their products likely the most regulated industries/products, but … perhaps aircraft industry regulations have achieved globally better results  Most journeys by air from A to B are very effective and safe (very high % starting the journey reaches from A to B, almost all getting in air land safely as well) „  If the aircraft business would be globally regulated as good or bad as medicines today  Perhaps quite high % of planes would not take off the ground or would not reach the destination for quality reasons  Not talk about the inherent relative lack of efficacy of many medicines In case of medicines it is not rare that from 100 persons starting the journey (treatment) only less than 10 may reach the destination (cure) Introduction to Regulatory AffairsSaturday, February 22, 2020 10 How medicines industry regulation compares with other well regulated industries?
  • 11. Regulatory Functions 22 February 2020Introduction to Regulatory Affairs 11
  • 12. Regulatory Marketing Authorization 22 February 2020Introduction to Regulatory Affairs 12
  • 13. Patent cliffs Exploding costs of drug discovery and development Much higher hurdles for approval for major indications Blockbuster strategy is dead Niche markets Orphan indications High failure rate – have to cover cost of failures in pricing of successful drugs Generic competition Big Pharma moving more toward Development and away from Discovery Introduction to Regulatory AffairsSaturday, February 22, 2020 13 Emerging Issues and challenges
  • 14. Scientific Regulatory Marketing Legal Healthcare Professional Patient Introduction to Regulatory AffairsSaturday, February 22, 2020 14 Emerging Issues and challenges
  • 15. Introduction to Regulatory Affairs 22 February 2020 15 Emerging Issues and challenges
  • 16.  From elementary quality requirements to safety and efficacy  From quality control of finished product to quality of manufacturing  From quality control of finished products and inspection of manufacturing sites in general to more understanding the processes and product specific process involved.  From rigid limits to agreed upon before hand set of limits which can be used by manufacturer in a more flexible manner Introduction to Regulatory Affairs 22 February 2020 16 Shifting Regulatory Paradigm
  • 17. Paradigm Increased role of science –new molecules, new advance therapies and combination of advance therapies (Medicine +MD) Paradigm From national to international- not a single regulator today work meaningfully in isolation and not using other regulators Paradigm Increasing need to decide what regulatory functions priorities nationally and what expertise /capabilities to build Introduction to Regulatory AffairsSaturday, February 22, 2020 17 Shifting Regulatory Paradigm
  • 18. Good Regulatory Practices Introduction to Regulatory Affairs 18 Principles of good regulatory practices Implementing good regulatory practices 22 February 2020
  • 19. Principles of good regulatory practices 22 February 2020Introduction to Regulatory Affairs  Legality: Regulation should have a sound legal basis and should be consistent with existing legislation, including international norms or agreements.  Impartiality: Regulation and regulatory decisions should be impartial in order to be fair and to avoid conflicts of interest, unfounded bias or improper influence from stakeholders.  Consistency: Regulations should be clear and predictable; both the regulator and the regulated party should understand the behavior and the conduct that are expected and the consequences of noncompliance.  Proportionality: Regulations and regulatory decisions should be proportional to the risk and should not exceed what is necessary to achieve the objectives. 19
  • 20. 22 February 2020Introduction to Regulatory Affairs  Flexibility: Regulations should not be prescriptive; they should allow flexibility in responding to a changing regulated environment and different or unforeseen circumstances.  Effectiveness: Regulations should produce the intended result.  Efficiency: Regulations should achieve their goals within the required time, effort and cost.  Clarity: Regulations should be accessible to, and understood by, the users;  Transparency: Regulatory systems should be transparent; requirements and decisions should be made known to affected parties and, where appropriate, to the public in general. 20 Principles of good regulatory practices
  • 21. Implementing good regulatory practices 22 February 2020Introduction to Regulatory Affairs 21  GRP in the pharmaceutical industry  Quality assurance in the pharmaceutical industry
  • 22. 22 February 2020Introduction to Regulatory Affairs 22