REGULATORY AFFAIRS

Pharma Regulatory Affairs

P.ANNAPURNA

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 Regulatory Affairs Overview

Regulatory Affairs (RA), also called Government

Affairs, is a profession within regulated industries,
such as pharmaceuticals, medical devices etc.

Regulatory Affairs professionals Ensures that their

companies comply with all of the regulations and
laws pertaining to their business.

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 Regulatory Affairs Overview
Regulatory affairs professionals Works with
federal, state, and local regulatory agencies and
personnel on specific issues affecting their
business. i.e. working with such agencies as the
Food and Drug Administration or European
Medicines Agency (pharmaceuticals and medical
devices);
The regulatory function in healthcare industries is
vital in making safe and effective healthcare
products available worldwide.

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 Regulatory Affairs Overview
Individuals who ensure regulatory compliance and
prepare submissions, as well as those whose
main job function is clinical affairs or quality
assurance are all considered regulatory
professionals.

Regulatory professionals are employed in industry,

government and academia and are involved with a
wide range of products, including:
Pharmaceuticals, medical devices, biologics and
biotechnology, nutrional products, cosmetics and
veterinary products. 1
 Regulatory Affairs Overview

• The regulatory professional's roles and

responsibilities often begin in the research
and development phases, moving into clinical
trials and extending through premarket
approvals, manufacturing, labelling and
advertising and post market surveillance.

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 Regulatory Affairs Overview
Core Competencies
 Regulatory professionals come from diverse
backgrounds. Most regulatory professionals have
earned a bachelor's degree, and more than half
have an advanced degree, most often in a scientific
or technical field. In addition, regulatory
professionals usually have experience in other
careers before transitioning into regulatory affairs.
 Continuing education and professional development
are critical to the regulatory professional. Regulatory
professionals must keep up to date with regulatory
policies and procedures for one or more countries,
as well as maintain an understanding of the scientific
and technical background of healthcare products.
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 Regulatory Affairs
Knowledge
• Regulated Countries

• Semi-regulated Countries

• Non-Regulated Countries

• Stability

• Knowledge of cGMP and other (ICH, CFR) Guidelines

• Technology transfer

• Validation
• Documentation
• Bioavailability and Bioequivalence studies (BA & BE)
• Patents 1
 Regulatory Affairs
Knowledge
• REGULATED MARKET: The regulated pharmaceutical
markets are those markets where drug approval
processes are very strict. They follow intellectual
property regulations which are harmonised with
regulatory authorities (FDA, EU/EMEA) procedures,
with strict patents, pricing and other regulatory rules.
e.g. USA, Europe, Japan, Australia, Finland.
• SEMI REGULATED MARKET: Where regulatory
requirements are relatively less stringent than
regulated but more stringent than non regulated
markets.
e.g. GCC Countries, Maxico, Brazil, CIS countries
(Russia, Ukraine etc.) Indonesia, Malaysia etc.

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 Regulatory Affairs
Knowledge
• NON REGULATED MARKET: Where regulatory
requirements are very simple.
e.g. Pakistan, India, SriLanka, Kenya, Cambodia,
Bangladesh etc.

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 Regulatory Affairs
Drug applications

 Types of Drug Applications (API)

DMF (Drug master file)

ASMF(Active Substance Master File-Europe)
USDMF

 Types of Drug Applications (Formulations)

• IND (Investigational New Drug Application)

• NDA(New Drug Application)
• ANDA(Abbrevated New Drug Application)
• BLA(Therapeutic biological application) 1
 Regulatory Affairs
Types of formats for the submission of drug
applications

CTD (Common Technical Document)

eCTD (Electronic Common Technical Document)

ACTD( Asean Common Techincal Document)

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 REGULATORY AFFAIRS
CTD

1.0Regional Administrative Information

1.1ToC of Module 1 or overall ToC,
Module 1 including Module 1
1.0
2.1ToC of the CTD (Mod 2,3,4,
2.1 2.2Introduction
Module 2 2.2 2.3Quality Overall Summary
2.4Nonclinical Overview
2.4 2.5
2.3 2.5Clinical Overview
2.6 2.7 2.6Nonclinical Summary
Module 3 Module 4 Module 5 2.7Clinical Summary
Quality Nonclinical Clinical
3.0 Study Reports Study Reports
4.0 5.0
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 REGULATORY AFFAIRS
ACTD

Part I: Table of Contents, Administrative Data and

Product Information

Part II: Quality Document

Part III: Nonclinical Document

Part IV: Clinical Document

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 Regulatory Affairs

Regulatory Authorities
USA- USFDA (United States of Food and Drug
Administration)
Australia- DHAC (Department of Health and Aged
Care) TGA (Therapeutic Goods Administration)
European Union- EMEA (European Medicines
Agency)
Procedures for dossier submission in European
Union.
National Procedure
Decentralized Procedure
Mutual Reorganization Procedure
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 METABOLISM & PHARMACOKINETICS
Contd..

• Design and Conduct of :

• Pharmacokinetic
• Toxicokinetic
• Metabolism studies in lab animals & humans

• Theoretical & Practical experience with

• HPLC,
• LC-MS / MS
• TLC
• Radiometric methods in biological fluids.

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 PHARMACOLOGY

• Responsibilities:

• Development – Validation - Assay of Drugs & Metabolites.

• Knowledge of HPLC and LC-MS/ MS.

• Apply new and existing Bio-analytical Techniques for Drugs &

Metabolites.
•
• Handle experimental problems independently

• Working familiarity with GLP.

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 CURRENT INDUSTRY OPINION
• Pharmacy Graduates / Post Graduates

Under equipped :

Practical Knowledge, Technical Skills

Lack of Exposure on :

Latest Developments in Pharma Industry.

Industry Pharmacy Curriculum

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 PHARMACY CURRICULUM

IS THERE ANY NEED TO CHANGE?

YES

• Periodical change in curriculum was the concept in yester years.

• Since Pharma Industry has under gone a rapid change in:

 Focus
 Direction
 Functioning

• There is necessity to update the curriculum from time to time

• It should be a continuous process and be need based.

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 NEED OF THE HOUR
 Acquaint the pharmacy students in:

Documentation of Processes

• Good Clinical Practices (GCP),

• Process Analytical Techniques

• Innovations in Pharma Formulation Technology

• Intellectual Property Rights (IPR).

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 NEED OF THE HOUR
Contd..
• Acquaint the pharmacy students in:

• Quality Management

• Regulatory Management

• Discovery Research.

• Disease Management

• Clinical Pharmacy:
• Patho-physiology
• Total Parenteral Nutrition
• Pharmaco-therapeutics

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 NEED OF THE HOUR
Contd..
• Acquaint the pharmacy students in:

• Knowledge of Protocols for Bio-Equivalence

• Methods of Analysis

• Validations for Product Quality

• Process Efficiency for reducing product failures

• Scale up techniques,

• Knowledge & Implications of GLP.

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 NEED OF THE HOUR
Contd..
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SOFT SKILLS :

Personality Development & Positive Attitude

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1 Communication Skills & Shop Floor Relations.

Command over English Language.

1 Commitment.

1 Sincerity & Dedication.

1 Ownership Feeling

1 Planning.

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 ADVISE TO FACULTY

• Introduce Reforms in teaching

methodology, pedagogy and methods of
evaluation.

• Training of the faculty through refresher

courses on latest technologies and in
plant training for effective and
meaningful teaching process.

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 ADVISE TO FACULTY

Acquire awareness about advances in pharmaceutical

industry and R&D through :

• Workshops
• Seminars
• Guests Lectures
• Visits to the Industry

• It is this lacuna which is to be rectified for effective

Pharma Education

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 GOOD PHARMACY EDUCATIONAL
PRACTICES

It is in this area we have to concentrate and make an impact on

value proposition.

Hence it is proposed to bring in certain evaluation methods

where in they have to be computed for awarding the degree.

To name a few :

Report writing after a industry Training / Visit.

Objective tests after a Guest Lecture / Seminar / Workshop
Project work in Community Pharmacy / Hospital.

Preparation of working models or fabrications need to be made

as evaluation components in awarding degrees

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 GOOD PHARMACY EDUCATIONAL PRACTICES

• To bring legislation for :

• Offering training to the students and staff of the institutions by

the industry.

• The Institution to provide consultancy services to the industry.

• Consequent upon implementing these recommendations:

• The institutions will provide the technical man power of highest

order & become centers for consultancy for the Pharma
industry.

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 JUST REMEMBER

NOTHING IS EVER A THREAT

IT IS ALWAYS AN OPPORTUNITY

IT IS WE WHO CONVERT
OPPORTUNITIES INTO THREATS

AND THREATS INTO GREAT OPPORTUNITIES

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