This document provides an introduction to regulatory affairs and good regulatory practices. It defines regulatory affairs as the interface between the pharmaceutical industry and drug regulatory authorities, and notes that regulatory affairs is involved in all stages of medicine development and post-marketing activities. The document then discusses the roles and responsibilities of regulatory professionals in liaising with health authorities, ensuring regulatory compliance, and managing product life cycles. It also outlines principles of good regulatory practices such as legality, impartiality, consistency, and transparency.

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
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Introduction to Regulatory Affairs

3. Introduction
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Introduction to Regulatory Affairs

4.  Production Department
 Quality Control Department
 Warehouse Department
 Finance Department
 Marketing Department
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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
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Introduction to Regulatory Affairs
Current Practices

6.  Pakistan Pharmaceutical Drugs Laws
 CTD/eCTD Dossier
 DMF/ANDA/NDA
 Bioequivalence Studies
 Basic GMP Documentations
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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
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Introduction to Regulatory Affairs
Roles & Responsibilities of RA
Professionals

8. Goals of Regulatory
Professionals
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 Protection of Human health
 Ensuring the safety, efficacy and safety of Drugs
 Ensuring the product information
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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
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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)
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How medicines industry regulation compares
with other well regulated industries?

11. Regulatory Functions
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12. Regulatory Marketing
Authorization
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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
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Emerging Issues and
challenges

14. Scientific
Regulatory
Marketing
Legal
Healthcare
Professional
Patient
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Emerging Issues and
challenges

15. Introduction to Regulatory Affairs 22 February 2020
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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
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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
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Shifting Regulatory Paradigm

18. Good Regulatory Practices
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Principles of
good regulatory
practices
Implementing
good regulatory
practices
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19. Principles of good regulatory
practices
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 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.
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 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.
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Principles of good regulatory
practices

21. Implementing good regulatory
practices
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 GRP in the pharmaceutical industry
 Quality assurance in the pharmaceutical
industry

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