The document discusses the importance of regulatory affairs in the pharmaceutical industry. It describes how regulatory affairs acts as the bridge between pharmaceutical companies and government regulatory agencies by ensuring drug products meet all necessary quality, safety, and efficacy standards before and after approval. Key responsibilities of regulatory affairs include managing clinical trials and submissions, maintaining compliance with all regulations, and advising companies on regulatory requirements and strategies. Strict regulations are necessary to protect public health after past drug failures and disasters.

1. BY,
Dr. Jigar Vyas
Professor and Vice-Principal
Sigma Institute of Pharmacy
Regulatory Affairs

2. 1 02/15/17
The Bridge
Between Pharma
Companies &
Govt. Agency
Dr. Jigar Vyas, RA

3. 3
Dr. Jigar Vyas, RA

4. What
i
s
this?
4
Dr. Jigar Vyas, RA

5. By whom? (the authority)
no (=does not belong to
drug regulatory affairs)
yes
Prior authorisation needed?
Based on which (objective
and subjective) criteria?
Subject to regular control
(quality, inspection)?
By whom? (the authority)
Based on which (objective
and subjective) criteria?
5
Dr. Jigar Vyas, RA

6.  research (chemical, biological)
 clinical trials on human beings
 manufacture
 registration
 evaluation
 authorisation
 (wholesale) distribution
continued
6
Dr. Jigar Vyas, RA

7.  pricing
 prescribing
 reimbursement/subsidy
 advertising (if any)
 special control (e.g. narcotics)
 post-marketing surveillance
 national drug quality control lab
 adverse effect reporting system
 (retail) distribution etc.
poppy
7
Dr. Jigar Vyas, RA

8.  Introduction

A new molecule can cost several millions of rupees or dollars to
progress and any blunder causes greater impact on company’s status.
As medicines play a vital role in human’s life there must be regulations
for medicines ensuring Quality, Safety and Efficacy of drugs.
 The regulatory affairs professional is the only one who is completely
responsible for holding products in compliance and maintaining all the
records.
 One of the vital activities of the regulatory specialist is to ensure that
the all the information regarding medicines has been correctly
established to the patient covering labelling also. Even a small mistake
in any of the activities related to regulatory can make the product to be
recalled in addition to loss of several millions of the money.
8
Dr. Jigar Vyas, Regulatory Affairs

9.  Drug development to commercialization is highly regulated. Every
drug before getting market approval must undergo rigorous scrutiny
and clinical trials to ensure its safety, efficacy and quality.
 These standards are set by regulatory authorities of their respective
countries such as FDA in US and DCA in India etc. Regulation affects
all aspects of the pharmaceutical world, from independent innovators
and pharmaceutical companies to regulatory and administrative bodies
and patients also.
 Regulatory department is crucial link between company, products and
regulatory authorities whose positive or negative standpoint foster the
insight of the regulatory authority into the industry, for good or for
bad. So, the better the scientific precision, the greater will be the
chances for a product to come to the market within the expected time.
9
Dr. Jigar Vyas, Regulatory Affairs

10.  Regulation and regulatory Affairs
Regulation involves extensive evaluation
of a particular drug product to ensure
protection of public health, promotion of the product, Drug
registration, marketing authorization, import and
distribution, pharmacovigilance.
Regulatory Affairs is a comparatively new profession which
has developed from the desire of governments to protect
public health, by controlling the safety and efficacy of
products in areas including pharmaceuticals, veterinary
medicines, medical devices, pesticides, agrochemicals,
cosmetics and complementary medicines.
10
Dr. Jigar Vyas, Regulatory Affairs

11. Regulatory Affairs is a unique mixture of
Science and Management
to achieve a commercially important goal within a drug-development
organization.
Regulatory Affairs takes care of
 Development plan,
 supervising-writing / reviewing and
 assembling and
 submission management.
They give strategic and technical advice at the highest level in their companies,
right from the beginning of the development of a product, making an
important contribution both commercially and scientifically to the success of a
development programme and the company as a whole.
11
Dr. Jigar Vyas, Regulatory Affairs

12.  Generation of various Regulations (Evolution)
Major incidences made us to understand that rules and regulations are
required to prove safety along with efficacy of drug.
Such incidences are as follows:
-Diphtheria Epidemic led to 1902 Biologics Control Act
-Publication of The Jungle by Upton Sinclair led to 1906 Pure Food
and Drugs Act
-Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act
-Thalidomide led to the 1962 Kefauver-Harris Amendments
-Dalkon Shield led to the 1976 Medical Device Amendments
-Bjork-Shiley Heart Valves led to the 1990 Safe Medical Devices Act
12
Dr. Jigar Vyas, Regulatory Affairs

13.  Passing of the 1938 Food Drug and Cosmetic Act,
Elixir sulfanilamide was an improperly prepared sulfanilamide
medicine that caused mass poisoning in the United States in 1937. It
caused the deaths of more than 100 people. The public outcry caused
by these incident and other similar disasters led to the passing of the
1938 Federal Food, Drug, and Cosmetic Act.
13
Dr. Jigar Vyas, Regulatory Affairs

14.  Passing of the 1938 Food Drug and Cosmetic Act,
In 1937, S. E. Massengill Company, a pharmaceutical manufacturer,
created a preparation of sulfanilamide using diethylene glycol (DEG) as
a solvent, and called the preparation "Elixir Sulfanilamide". DEG is
poisonous to humans, but Harold Watkins, the company's chief
pharmacist and chemist, was not aware of this (although it was known
at the time). Watkins simply added raspberry flavoring to the sulfa
drug which he had dissolved in DEG and the company then marketed
the product. Although animal testing should have been routine in most
drug company operations, Massengill performed none and there were
no regulations requiring premarket safety testing of new drugs.
14
Dr. Jigar Vyas, Regulatory Affairs

15.  Passing of the 1938 Food Drug and Cosmetic Act,
The company started selling and distributing the medication in
September 1937. By October 11, the American Medical Association
received a report of several deaths caused by the medication. The Food
and Drug Administration was notified, and an extensive search was
conducted to recover the distributed medicine. Frances Oldham Kelsey
assisted on a research project that verified that the excipient DEG was
responsible for the fatal adverse effects. At least 100 deaths were
blamed on the medication. Congress responded to public outrage by
passing the 1938 Food, Drug, and Cosmetic Act, which required
companies to perform animal safety tests on their proposed new drugs
and submit the data to the FDA before being allowed to market their
products.
15
Dr. Jigar Vyas, Regulatory Affairs

16.  Qualities of a good RA professional
Ø Authoritative
Ø Team Player
Ø Decisive
Ø Resourceful
Ø Good Communication Skill
Ø Analytical Skill- Ability to evaluate the strengths and
weakness of the technical and legal options open to a
company.
Ø Good Informational Technology skills
Ø Negotiating Skills
Ø Able to reapply scientific and regulatory principles
Ø Ability to work with other disciplines
Ø Flexible- Always willing to learn.
16
Dr. Jigar Vyas, Regulatory Affairs

17.  Responsibilities of Regulatory Affairs Department
Ø Keep in touch with international legislation, guidelines and customer
practices
Ø Keep up to the date with a company’s product range
Ø Ensure that a company’s products comply with the current regulations.
Ø The Regulatory Affairs professional’s job is to keep track of the ever-
changing legislation in all the regions in which the company wishes to
distribute its products. They also advise on the legal and scientific restraints
and requirements, and collect, collate, and evaluate the scientific data that
their research and development colleagues are generating.
Ø Formulate regulatory strategy for all appropriate regulatory submissions for
domestic, international and/or contract projects.
Ø Coordinate, prepare and review all appropriate documents for example
dossier and submit them to regulatory authorities within a specified time
frame in conjugation with the organization.
Ø Prepare and review of SOPs related to RA. Review of BMR, MFR, change
control and other relevant documents.
17
Dr. Jigar Vyas, Regulatory Affairs

18.  Responsibilities of Regulatory Affairs Department cont...

Ø Monitor the progress of all registration submission
Ø Maintain approved applications and the record of registration fees paid against
submission of DMF’s and other documents.
Ø Respond to queries as they arise, and ensure that registration/ approvalare granted
without delay.
Ø Impart training to R&D, Pilot plant, ADl and RA. Team members on current
regulatory requirements.
Ø Advising their companies on the regulatory aspects and climate that would affect
proposed activities. i.e. describing the "regulatory climate" around issues such as
the promotion of prescription drugs and Sarbanes-Oxley compliance.
Ø Manage review audit reports and compliance, regulatory and customer inspections.
Ø Regulatory Affairs professionals help the company avoid problems caused by badly
kept records, inappropriate scientific thinking or poor presentation of data. In
most product areas where regulatory requirements are imposed, restrictions are
also placed upon the claims which can be made for the product on labelling or in
advertising.
Ø Have a duty to provide physicians and other healthcare professionals with accurate
and complete information about the quality, safety and effectiveness of the
product.
18
Dr. Jigar Vyas, Regulatory Affairs

19.  Why is Regulatory Affairs important?
In today’s competitive environment the reduction of the time taken to
reach the market is vital to a product’s and hence the company’s
success. The proper conduct of its Regulatory Affairs activities is
therefore of considerable economic significance for the company.
Inadequate reporting of data may prevent a timely positive evaluation
of a marketing application. A new drug may have cost many millions of
pounds, Euros or dollars to develop and even a three-month delay in
bringing it to the market has considerable financial considerations.
Even worse, failures to fully report all the available data or the release of
product bearing incorrect labelling, may easily result in the need for a
product recall.
19
Dr. Jigar Vyas, Regulatory Affairs

20. 2
0

21. Phase Number of
patients
Length Purpose Percent
successfully
completing
Phase1 20-100 Several months Mainly safety
67
Phase2 Up to several
hundred
Several months
to two years
Some short-term
safety but mainly
effectiveness
45
Phase3 Several hundred 1-4 years Safety,
to several
thousand
effectiveness,
dosage
5-10
6
21

22.  Why is Regulatory Affairs important? Cont...
A good Regulatory Affairs professional will have a ‘right first time’
approach and will play a very important part in coordinating scientific
endeavour with regulatory demands throughout the life of the product,
helping to maximise the cost-effective use of the company’s resources.
The Regulatory Affairs department is very often the first point of
contact between the government authorities and the company.
Officials respond much better to a company whose representatives are
scientifically accurate and knowledgeable than to one in which these
qualities are absent.
22
Dr. Jigar Vyas, Regulatory Affairs

23.  Regulatory Affairs Profession
The (Healthcare) Regulatory Affairs Profession is still an emergent
profession but has two major international professional membership
societies:
The Regulatory Affairs Professionals Society, RAPS,
The Organisation for Professionals in Regulatory Affairs, TOPRA,
In Canada, the major professional membership society is: The Canadian
Association of Professional Regulatory Affairs, CAPRA,
23
Dr. Jigar Vyas, Regulatory Affairs