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AN OVERVIEW OF REGULATORY AFFAIRS IN PHARMACEUTICAL INDUSTRY

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158 | P a g e International Standard Serial Number (ISSN): 2319-8141
International Journal of Universal Pharmacy and Bio Sciences 9(4): July-August 2020
INTERNATIONAL JOURNAL OF UNIVERSAL
PHARMACY AND BIO SCIENCES
IMPACT FACTOR 4.018***
ICV 6.16***
Pharmaceutical Sciences Review Article……!!!

AN OVERVIEW OF REGULATORY AFFAIRS IN PHARMACEUTICAL

INDUSTRY
Mr. Rajesh Dumpala1*, Mr. Chirag Patil2
1
Research Scientist, Dept. F&D-(MS&T) Alembic Research Centre, Vadodara, Gujarat, India.
2
Research Associate, Dept. F&D-(MS&T) Alembic Research Centre, Vadodara, Gujarat, India.

KEYWORDS: ABSTRACT
Pharmaceutical drug regulatory affairs covers different registration
Regulatory affairs,
parameter of pharmaceutical product .As it is the new profession
Pharmaceutical industries,
which was developed from the desired of all over the world to
World regulatory bodies.
protect the public health by providing good quality of medicine
FOR
including safety and efficacy in the area of not only pharmacy but
CORRESPONDENCE:
also in the area of the veterinary medicine, medical device,
Mr. Rajesh Dumpala*
insecticides , pesticides, agrochemical, cosmetic and
ADDRESS:
complementary medicine .It also made the interface between the
Research Scientist, Dept.
pharmaceutical company and the regulatory agencies . It is also
F&D-(MS&T) Alembic
responsible for maintaining the appropriateness and accuracy of
Research Centre,
the product information. And its main role to act as an liaison with
Vadodara, Gujarat, India.
regulatory agencies , providing expertise and regulatory
intelligence in translating regulatory requirement into practical
workable plan , advising the company on regulatory aspects and
climate that would affect their proposed activities.

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INTRODUCTION:
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries,
such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs also has a very
specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and
functional foods) [1]. Most companies, whether they are major multinational pharmaceutical
corporations or small, innovative biotechnology companies, have specialist departments of Regulatory

Affairs professionals [2].

As it is heart of all about Collecting, Analyzing and Communicating the Risks and Benefits of health
care products to regulatory agencies and public all over the world. It is also a science of developing
new tools, standards and approaches to assess the safety, efficacy, quality and performance of
regulated products All medicines must meet three criteria: be of good quality, safe and effective.
The judgments about medicines quality, safety and efficacy should be based on solid science.
The success of regulatory strategy is less dependent on the regulations than on how they are
interpreted, applied, and communicated within companies and to outside constituents [3]. Pharma
regulatory affairs professionals play an essential role in ensuring all pharmaceutical products

comply with regulations governing the industry [4]. Those working in pharma regulatory affairs
jobs not only work in the initial application phase for a new or generic drug, but also in the licensing
and marketing stages – making sure all operations and products meet required safety and efficacy
standards. Professionals must combine knowledge of the business, legal and pharmaceutical
industries to determine if regulations are being followed and in many cases form the link between
pharma companies and regulatory authorities, such as the Food and Drugs Agency (FDA) and the

European Union [5].

FIG- 1 Roles or interactions of RA

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WHY NEEDTO REGULATE
1.All substances are poisons; there is none which is not a poison.The right dose differentiates a
poison and a remedy
2.To ensure quality, safety and efficacy of drug products in order to assure the continued
protection of Public Health.
3.No drug product is completely safe or efficacious in all circumstances, but there is a moral, as well
as legal, expectation that appropriate steps are taken to assure optimal quality, safety and efficacy by
the Producers concerned. Benefit versus Risk.
PHARMACEUTICAL DRUG REGULATORY AFFAIRS
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 [6].The companies manufacture and marketing these
products must ensure that they supply Quality products to public for their health and welfare. Now
most of the companies have specialist departments of Regulatory Affairs professionals.
Regulatory Affairs typically communicates with one of the Centers (e.g., Center for Drug
Evaluation and Research) at the FDA headquarters, rather than the FDA local district offices.
Gimps do not directly apply to Regulatory Affairs; however, they must understand and evaluate
changes to drug manufacturing and testing activities to determine if and when the FDA must be
notified. The companies responsible for the discovery, testing, manufacture and marketing of these
products also want to ensure that they supply products that are safe and make a worthwhile
contribution to public health and welfare. The Regulatory Affairs (RA) departments must be

aware of the regulatory requirements in all the company's export markets[7].

REGULATORY AFFAIRS PROFESSION
The pharmaceutical research and development process of bringing a new drug to the market takes
many years; it is therefore essential that the process be managed effectively from beginning to end
in order to meet the regulatory requirements and permit a favorable evaluation of efficacy and

safety in the shortest possible time [8]. The drug regulatory affairs (DRA) professional plays an
important role in every phase of this process, from developing regulatory strategies following the
discovery of a new chemical entity to planning post- marketing activities.
In this position, the DRA professional must possess a proficient scientific background (B.Sc, M.Sc.,
Ph.D., M.D. B. Pharm, M.Pharm or Pharm.D.) and have acquired a thorough knowledge of Indian

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regulations as well as international regulations [9].

The DRA professional must actively participate in discussions and coordinate team activities to
obtain all the necessary documentation and then assess it for completeness and accuracy.
Therefore, an effective DRA professional must exhibit the organizational and interpersonal skills
of a "team player" and also be thorough and detail oriented.

Fig 2: The spectrum of regulatory affairs

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CHALLENGETO REGULATORY AFFAIRS PROFEESION
Regulatory affairs include complete dynamics:
 Multi –dimensional
 Knowledge in science and technology
 Prolific communication skill
 Deal with people with diverse background, skills, culture, and personalities
 Deal with conflicting loyalties, motivations, social and ethicals, responsibilities
Case in point: submission of a dossier
During submission of a dossier a regulatory affair would be:
 Guided by various regulatory guidance
 Receiving input from various department within the firm about process capabilities and
product attribute specification
 Receiving advice from peers about easy way to get approvals
 Receiving motivation from the management through incentives for achieving speedy
approvals
PRODUCT LIFE CYCLE - REGULATORY AFFAIRS PERSPECTIVE
The role of regulatory affairs – development phase
– Ensuring that the legislative requirements are met
 Arrange for Scientific Advice - authorities
 Advice on development studies to demonstrate safety, quality and efficacy
– Set up regulatory strategy
– Participate in cross-functional project teams
– Ensure application of guidelines
– Preparation of submission of application to conduct clinical trials
– Managing the preparation of the regulatory submission
 Minimize time to market (every day counts!)
 Advice on a global development plan
– Optimize submission strategies
 Efficiency in dossier preparation
– Format, document re-uses
– Electronic submissions
– Internal company relationships, project management

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– Review high-level documents/reports
 Interact with commercial side of business such as pricing and reimbursement
The role of regulatory affairs – approval phase
 Check progress of evaluation and anticipate questions
 Clarify raised questions, plan response and strategies with other departments
 Plan and manage agency meetings/hearings
 Negotiate approval and Product Information with agencies
The role of regulatory affairs – post approval phase
– Compliance
 Submission of variations/amendments
– Renewals
– Pharmacovigilance
– Product information review
– New indications / new formulations
 Regulatory input to development plans!
– Regulatory Intelligence
 What does the future hold?
THE VARIOUS ROLES WITHIN REGULATORY AFFAIRS
 Project management
 Submission management
 Maintenance management
 CMC specialist
 Pre-clinical/Clinical specialist
 Labeling expert
 Regulatory intelligence
 Global versus local Regulatory Affairs
REGULATORY STRATEGY
 Planning of regulatory affairs
 Planning of addressing critical development issues, which is dynamic and changes during the
process
 Plan of how to register a product in the global market (to be in line with corporate, business and
strategy of RA unit and projects)

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 Plan how to balance time & cost & human resources Strategy is only as good as the
analysis behind it.
MAJOR REGULATORY AUTHORITY OF DIFFERENT COUNTRIES
S.NO COUNTRIES REGULATORY AUTHORITIES
 Central drug standard control organization
1 India
 Drug controller general of India(DCG)
2 US Food and drug administration (USFDA)
Medicine and health care products regulatory
3 UK
agencies (MHRA)
4 Australia Therapeutics good administration (TGA)
Japanese ministry of health, labour and
5 Japan
welfare (MHLW)
6 Canada Health Canada
Agency Nacional degradation vigilancia
7 Brazil
sonotoria (ANVISA)
8 South Africa Medicine control council (MCC)
 European directorate for quality of medicine (EDQM)
9 Europe  European medicines evolution agencies
(EMEA)
EXPECPTION FROM THE REGULATORY AFFAIRS AGENCIES
 To ensure that a dossier results in a SmPC (Summary for the prescribers Package leaflet –
Information for the patient) that results in sales
 To ensure that the regulators are the first supportive customers for the product
 Networking, regulatory intelligence
 The integration of regulatory into the discovery and development process
IMPORTANCE OF REGULATORY AFFAIRS
In today's competitive environment the reduction of the time taken to reach the market is critical to a
product's and hence the company's success. The proper conduct of its Regulatory Affairs activities is
therefore of considerable economic importance for the company.
REPORTING OF REGULATORY AFFAIRS
 Medical Director
 Research & Development Director

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 Quality Management Director
 Commercial Director
 Managing Director or chief executive officer
ORGANIZATIONAL STRUCTURE OF REGULATORY AFFAIRS
Not unified across the companies and is changing
 Global regulatory affairs
 Regional regulatory affairs
 Local regulatory affairs
 Manufacturing site regulatory affairs
 Drug Agency regulatory affairs
The structure will depend on size, type and culture of the company and the personalities involved
The importance of the Regulatory Affairs function is such that senior
Regulatory Affairs professionals are increasingly being appointed to boardroom positions, where they
[10]
can advise upon and further influence the strategic decisions of their companies .
Regulation is a binding instruction issued by an agency that tells how to interpret and comply with a
law. Failures to follow the regulations may end up in the “issued warning letter” section of the FDA
website, which is not a good for a Pharma company.
RESPOSIBILITIES OF REGULATORY AFFAIRS AGENCIES
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[11].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

program and the company as a whole [12].

Some of the responsibilities of Regulatory Affairs Department
 Ensuring that their companies comply with all of the system policy and laws pertaining to their
business.
 Working with federal, state, and local regulatory agencies and staff on specific issues
distressing their commerce. i.e. working with agencies as the Food and Drug Administration or
European Medicines Agency.
 Advising their companies on the regulatory aspects and climate that would affect proposed

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actions
 I.e. describing the "regulatory climate" in the region of issues such as the endorsement of
prescription drugs.
 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.
 Prepare and review of SOPs related to regulatory affairs. Review of BMR, MFR, change control and

other relevant documents[13].

 Respond to queries as they arise, and ensure that registration/ approval are granted without delay
[14].

 Impart training to R&D, Pilot plant, ADl and regulatory affairs.

 Have a duty to provide physicians and other healthcare professionals with accurate and complete
information about the quality, safety and effectiveness of the product.
RECENT ADVANCEMENT IN DRUG REGULATORY AFFAIRS
Recently, the Govt. of India has constituted a few autonomous bodies to gauge the standards of
profession of Pharmacy & grade the colleges accordingly so that the students, parents, employers
and funding agencies have a valid & reliable rating of the various Pharmacy colleges in the

country.[15]
These are:
(1) National Board of Accreditation (NBA) under the aegis of All India Council for Technical
Education.
(2) National Assessment and Accreditation Council (NAAC) by the University Grants
Commission.
SCOPE OF REGULATORY AFFAIRS PROFESSIONAL IN INDUSTRIES
Regulatory affairs professionals are employed in industry, government regulatory authorities and
academics. The wide range of regulatory professionals includes in these areas:
 Pharmaceuticals
 Medical devices
 In vitro diagnostics
 Biologics and biotechnology
 Nutritional Products
 Cosmetics

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 Veterinary Products
CONCLUSION
Regulatory Affairs department is constantly evolving and growing and is the one which is least
impacted during the acquisition and merger, and also during recession. Regulatory Affairs
departments are growing within companies. Due to the changing resources necessary to fulfil the
regulatory requirements, some companies also choose to outsource or out task regulatory affairs to
external service providers. In today’s competitive environment the reduction of the time taken to
reach the market is critical to a product and hence the company’s success. The proper
implementation of regulatory guidelines and laws will improve the economic growth of the
company and also improves the safety of the people.
REFERENCES:
1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at
http://en.wikipedia.org/wiki/Regulatory Affairs.
2. International regulatory affair updates 2005 available at http://www.iraup.com/about.php
3. “Douglas J Pisano and David S. Mantus”‘Text book of FDA Regulatory Affairs A Guide for
Prescription Drugs, Medical Devices, and Biologics’.2nd edition , August 2008.
4. Topra brought by dimension associates [online] Available from
http://www.topra.org/careers/what-regulatory-affairs.
5. “ Douglas J. Pisano and David S. Mantus”‘Text book of FDA Regulatory Affairs A Guide for
Prescription Drugs, Medical Devices, and Biologics’Second Edition, August 2008.
6. “Careers in Regulatory Affairs from Practitioner to professional,” Naturejobs Biotechnology,
2002;20(4): 409-41.
7. Regulatory Affairs Management [online]. Avalible from:
http://medind.nic.in/haa/t06/i1/haat07i1p51.
8. http://www.medindia.net/indian_health_act/drugs-andcosmetics-act-1940 introduction
9. Topra brought by dimension associates availableat http://www.topra.org/careers/whatregulatory-
affairs.
10.Guide to good storage practices for pharmaceuticals. WHO Expert Committee on Specifications
for Pharmaceutical Preparations. Thirtyseventh Report. Geneva, World Health Organization, 2003
(WHOTechnical Report Series, No. 908, Annex 9).
11.WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty- eighth Report.
Geneva, World Health Organization, 2004.
12.Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource

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(Generic) Products – A Manual for a Drug Regulatory Authority. Geneva, World Health
Organization, 1999 (Regulatory Support Series, No. 5, WHO/DMP/ RGS/98.5).
13.A Model Quality Assurance System for Prequalification, Procurement, Storage and Distribution of
Pharmaceutical Products. Geneva, World Health Organization, 2003.

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