ROLE OF REGULATORY AFFAIRS IN A PHARMACEUTICAL INDUSTRY

Abstract

Abstract: Regulatory affairs (RA) professionals play critical roles in a pharmaceutical industry because it is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. The role of regulatory affairs is to develop and execute a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is approvable by global regulators but is also differentiated from the competition in some way and also is to ensure that the company’s activities, from non-clinical research through to advertising and promotion, are conducted in accordance with the regulations and guidelines established by regulatory authorities. Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.

Full text

Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS
Available Online at www.ijprbs.com
170
ROLE OF REGULATORY AFFAIRS IN A PHARMACEUTICAL INDUSTRY
Y. SRI HARSHA, V.SHARMILA REDDY, D. MARY, D.NAGARJUNAREDDY, M. V.
NAGABHUSANAM, BRAHMAIAH BONTHAGARALA.
Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Amaravathi
Road, Guntur, Andhra Pradesh, India-522002.
Accepted Date: 23/04/2017; Published Date: 27/04/2017
Abstract: Regulatory affairs (RA) professionals play critical roles in a pharmaceutical industry
because it is concern about the healthcare product lifecycle, it provide strategic, tactical and
operational direction and support for working within regulations to expedite the development
and delivery of safe and effective healthcare products to individuals around the world. The
role of regulatory affairs is to develop and execute a regulatory strategy to ensure that the
collective efforts of the drug development team results in a product that is approvable by
global regulators but is also differentiated from the competition in some way and also is to
ensure that the company’s activities, from non-clinical research through to advertising and
promotion, are conducted in accordance with the regulations and guidelines established by
regulatory authorities. Regulatory Affairs is an attractive career choice for graduate students
from a scientific background who enjoy communication and team work, are comfortable with
multi-tasking and are eager to expand their knowledge in the wide realms of the
Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly
regarded profession within pharmaceutical companies.
Keywords: Regulatory Affairs, Pharmacy Practice, Pharmacy Curriculum, Worldwide
Regulatory Agencies.
INTERNATIONAL JOURNAL OF
PHARMACEUTICAL RESEARCH AND BIO-SCIENCE
PAPER-QR CODE
Corresponding Author: MS. Y. SRI HARSHA
Access Online On:
www.ijprbs.com
How to Cite This Article:
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177

Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS
Available Online at www.ijprbs.com
171
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) most companies, whether they are major multinational
pharmaceutical corporations or small, innovative biotechnology companies, have specialist
departments of Regulatory Affairs professionals [1-4]. The current Pharmaceutical Industry is well
organized, systematic and compliant to international regulatory standards for manufacturing of
Chemical and Biological drugs for human and veterinary consumption as well as medical
devices, traditional herbal products and cosmetics. Stringent GMPs are being followed for blood
and its derivative as well as controlled manufacturing for Traditional Herbal Medicines,
Cosmetics, Food and Dietary products which was otherwise differently a century before. Each
regulatory system had faced certain circumstances which led to current well-defined controlled
regulatory framework. This has resulted into systematic manufacturing and marketing of
safe, efficacious and qualitative drugs. With the growth of industry, the legislations from each
region have become more and more complex and created a need for regulatory professionals
[2]. To understand the chronological development of the modern era of pharmaceutical industry
and regulatory framework, we will glance through the historical evolution of regulations in USA,
Europe and India [3-6].
OBJECTIVES OF REGULATORY AFFAIRS
 How and why the pharmaceutical industry and drug regulations have developed in USA
 Major Regulations of USA
 Framework of EU and its regulatory
 “The Rules Governing Medicinal Products in the European Union”
 Pharmaceutical Legislations of EU
 Indian Pharmaceutical Industry & Drug Regulations development in different Era
 Types of Marketing Authorization Procedure in EU Market
 Major Rules and Act of India
 Roles of Regulatory Affairs Professional in Health Authorities as well as Pharmaceutical
Industry

Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS
Available Online at www.ijprbs.com
172
WHAT IS REGULATORY AFFAIRS
It is a unique mix of science and management to achieve a commercially important goal within
a drug development organization. _Touches everything relating to drugs from the earliest non-
clinical studies, through development, into routine manufacture and marketing, can add
significant impact for patients and drug companies [7].
WHY IS REGULATORY AFFAIRS NEEDED
Drug development and commercialization is highly regulated the path to drug registration
Marketing Approval) is paved with good intention but can be complicated Things change
constantly.
PARAMETER OF REGULATORY AFFAIRS
 Design =Development Plan
 Co-ordination= Writing/reviewing, supervising
 Construction= Assembling & Submission Management
 Testing= Where are the weaknesses
 Drug regulations
 National Laws (e.g. UK - Medicines Act, US- CFR)
 Regional Laws (EC directives)
 National and Regional Guidelines
 International Guidelines (ICH)
REGULATORY BODIES IN THE WORLD
Table 1: Different regulatory bodies in the world
Country
Regulatory Body
USA
Food and Drug Administration (FDA)
UK
Medicines and Healthcare Products Regulatory
Agency (MHRA)
Australia
Therapeutic Goods Administration (TGA)

Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS
Available Online at www.ijprbs.com
173
India
Central Drug Standard Control Organization
(CDSCO)
Canada
Health Canada
Europe
European Medicines Agency (EMEA)
Japan
Ministry of Health, Labour& Welfare(MHLW)
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
HISTORICAL OVERVIEW OF REGULATORY AFFAIRS
During 1950s, multiple tragedies i.e. sulfanilamide elixir, vaccine tragedy and thalidomide
tragedy have resulted in substantial increase of legislations for drug products quality, safety and
efficacy. This has also resulted into stricter norms for Marketing Authorization (MA) and Good
Manufacturing Practices (GMPs).
PHARMACEUTICAL DRUG REGULATORY AFFAIRS
This department is responsible for knowing the regulatory requirements for getting new
products approved. They know what commitments the company has made to the regulatory
agencies where the product has been approved. They also submit annual reports and
supplements to the agencies. 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 [4], they must
understand and evaluate changes to drug manufacturing and testing activities to determine if

Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS
Available Online at www.ijprbs.com
174
and when the FDA must be notified. 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 [8-10]. 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. Regulatory [5] Affairs professionals, with their
detailed knowledge of the regulations and guidelines, are frequently called in to advice on such
matters.
IMPORTANCE OF REGULATORY AFFAIR
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.
Inadequate reporting of data may prevent a timely positive evaluation of a marketing
application. A new drug may have cost many millions of Euros or dollars, pounds, 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 labeling, may easily result in the need for a product recall [11-13]. Either
occurrence may lead to the loss of several millions of units of sales, not to mention the
resulting reduction in confidence of the investors, health professionals and patients [14]. The
Regulatory Affairs department is very often the first point of contact between the government
authorities and the company.
REGULATORY AFFAIRS IN PRODUCT MANAGEMENT
The key role of RA professional is broader than registration of products, they advise companies
both strategically and technically at the highest level. Their role begins right from development
of a product to making, marketing and post marketing strategies. Their advice at all stages both
in terms of legal and technical requirements help companies save a lot of time and money in
developing the product and marketing the same. For countries that do not have their on
regulations the World Health Organization guidelines on health matters and World Trade
Organization on trade regulations between nations is followed [14-16].
REGULATORY AFFAIRS IN CLINICAL TRIALS
The RA professional is the primary link between the company and worldwide regulatory
agencies such as US Food and Drug Administration (USFDA & Center for Devices and
Radiological Health) Medicines and Healthcare Products Regulatory Agency, United Kingdom,

Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS
Available Online at www.ijprbs.com
175
(UKMCA), Therapeutic Goods Administration, Australia European Medicines Agency,
Organization of Economic Collaboration and Development (OECD) and Health Canada. He also
communicates and interprets the seemingly endless mace of laws, regulations and guidelines to
the other departments of the company. The RA personnel develops strategies to overcome
delays and presents finding of clinical trials to the regulatory bodies so as to get quick clearance
thus reducing the time for approval of new molecules. At its core, the RA professional facilitates
the collection, analysis and communication about the risks and benefits of health products to
the regulatory agencies, medical and health systems and the public. Operationally RA is
responsible for assuring that government obligation, market driven demands and evolving
scientific conventions are understood and addressed by various stakeholders [14-16].
REGULATORY AFFAIRS IN R&D
The regulatory affairs personnel work hand in hand with marketing and R&D to develop,
innovative products that take advantage of new technological and regulatory developments to
accelerate time to market. With new products expected to add significant revenues to the
company’s bottom lines, small decreases in time to market equate to large material gains in
revenue and profit. Employing adaptive clinical trial strategies, obtaining quick approval from
regulatory authorities and avoiding pitfalls in processes can accelerate development of new
products and help to reduce costly errors and time lags [14-16].
WORKING OF REGULATORY AFFAIRS INFORMATION
Regulatory is the interface between the company/sponsor and the outside world the regulatory
department is a focal point of information, both incoming and outgoing. In order to practice
regulatory and succeed, both in objective public measures (e.g., approvals) and internal ones
(e.g., recognition and reward), etc.
GATHERING INFORMATION
All the information should be ethical proper documentation any opportunity to see, hears, or
talks with a regulator, a more experienced drug development expert, a colleague, or a sworn
enemy is an opportunity to gather information. There should be no need to go over published
sources of information, both commercial and governmental [11-13].
COMMUNICATING INFORMATION
The easiest way information is to share and communicate is non-critical information. The main
issue with such information is getting to the right audience without boring them into forgetting
that they’re getting useful data. Most companies subscribe to news updates or have internal
regulatory information updates through email. One suggestion is to make them playful and user

Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS
Available Online at www.ijprbs.com
176
friendly, using popular Web pages as guides. The difficult information to communicate is critical
information. This could mean anything vital to the success or failure of a project, specific and
important feedback from the FDA. The first thing to do is document the information carefully,
so that we can fully understand it and its implications. Then think of those individuals who are
that combination of “need to know” and “know who else needs to know.” At a small industry it
should be done by CEO or the president but in a larger companies, the head of clinical, a project
manager, should be handled [11-13].
NEED OF REGULATORY AFFAIRS IN THE PHARMACY CURRICULUM
India is growing very rapidly in pharmaceutical sector; there is a need of regulatory affairs
professionals to cater the current needs of industries for the global competition. Regulatory
affairs professionals are the link between pharmaceutical industries and worldwide regulatory
agencies. They are required to be well versed in the laws, regulations, guidelines and guidance
of the regulatory agencies. There is a growing need to incorporate the current requirements of
pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the
students with the latest developments to serve the industries [14-16].
CONCLUSION
Many in the Regulatory Affairs Profession believe the New Approach to regulation will
eventually be adopted for all healthcare products as it represents the best model for delivering
new healthcare advances to market in a reasonable time with acceptable safety. 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 fulfill 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’s and hence the company’s success. The proper
conduct of its Regulatory Affairs activities is therefore of considerable economic importance for
the company.
REFFERENCES
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’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at http,//www.cgmp.com/ra.htm.

Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713
Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS
Available Online at www.ijprbs.com
177
5. Training Needs in Regulatory Science for the Biopharmaceutical Industry, Nature Jobs
Biotechnology, 19(12), 2001, 1187-1188.
6. Careers in Regulatory Affairs from Practitioner to professional, Nature Jobs Biotechnology,
20(4), 2002, 409-410.
7. www.centerwatch.com.
8. www.regulatoryone.com
9. Sachin C Itkar, Dr. Ns Vyawahare, “Drug Regulatory Affairs”, Third edition (2015).
10. “Need For the Introduction of Regulatory Affairs in the Pharmacy Curriculum” Health
Administrator Vol: XIX Number 1: 51-52.
11. G.Sai Hanuja, B.Sai Kumari, M.V.Nagabhushanam, D.Nagarjuna Reddy, Brahmaiah
Bonthagarala, Regulatory Requirements for Registration of Generic Drugs in “BRICS” Countries,
International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6,
Vol. 6 , November-December 2016, 20-40.
12. B.Sai Kumari, G.Sai Hanuja, M.V.Nagabhushanam, D.Nagarjuna Reddy, Brahmaiah
Bonthagarala, Current Regulatory Requirements for Registration of Medicines, Compilation and
Submission of Dossier in Australian Therapeutic goods Administration, International Journal of
Advanced Scientific and Technical Research , ISSN 2249-9954, Issue 6 volume 6, November-
December 2016, 144-157.
13. Shaik Salman Basha, S. M. Shakeel, M. V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah
Bonthagarala, The Assesment of Current Regulatory Guidelines for Biosimilars- A Global
Scenario, World Journal of Pharmaceutical Research, ISSN 2277– 7105, volume 6, Issue 1, 351-
369.
14. S.M.Shakeel, Shaik Salman Basha, M.V.Nagabhushanam, D.Nagarjuna Reddy, Brahmaiah
Bonthagarala, Comparision of Regulataory Requirements for Generic Drugs Dossier Submission
in United States and Canada, International Journal of Pharmaceutical Science and Health Care,
ISSN 2249 – 5738, Issue 6, Vol. 6 , November-December 2016, 1-19.
15. Mounica N.V.N., Sharmila Reddy V, Anusha S, Evangeline L, Nagabhushanam M.V.,
Nagarjunareddy D, Brahmaiah B, Scale up and Post Approval Changes (SUPAC) Guidance for
Industry: A Regulatory Note, ISSN: 2321 – 6794, DOI:https://doi.org/10.22270/ijdra.v5i1.192,
International Journal of Drug Regulatory Affairs; 2017, 5(1), 13-19.
16. Sharmila Reddy V, Mounica N.V.N., Anusha S, Evangeline L, Nagabhushanam M.V.,
Nagarjunareddy D, Brahmaiah B, Regulatory Requirements of Similar Biologics for Marketing
Autharization in India, ISSN: 2321 – 6794, DOI:https://doi.org/10.22270/ijdra.v5i1.193,
International Journal of Drug Regulatory Affairs; 2017, 5(1), 20-24.