J.K.

Badjatya International Journal of Drug Regulatory Affairs; 2013, 1(1), 1-4 ISSN: 2321 - 6794

OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION

Available online at www.ijdra.com

REVIEW ARTICLE
Badjatya Jitendra Kumar *
Department of Pharmacy, JJT University, Chudela, Jhunjhunu, Rajasthan. India
*Corresponding Author’s E-mail: jeetbadjatya@gmail.com

ABSTRACT
Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrum
covering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulated
industries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceutical
industries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized various
industries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a very
specific meaning within the pharmaceutical industries.

DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionals
are dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.
RA as profession 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.
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 labeling or in advertising.
Keywords: Regulatory Affairs professionals, Regulatory agencies, CDER, MHRA, MOH

Introduction Drug Regulatory Affairs

Regulatory Affairs (RA), also called Regulatory Affairs is a new profession which is
Government Affairs, is a profession within
initiated from governments to protect public
regulated industries, such as pharmaceuticals, health, by controlling the safety and efficacy of
medical devices etc.
products in areas including pharmaceuticals,
RA profession at its heart is all about veterinary medicines, medical devices,
Collecting, Analyzing and Communicating the pesticides, agrochemicals, cosmetics and
Risks and Benefits of health care products to
complementary medicines. The companies
regulatory agencies and public all over the manufacture and marketing these products
world.
must ensure that they supply Quality products
A science of developing new tools, standards to public for their health and welfare. Now
and approaches to assess the safety, efficacy,
most of the companies have specialist
quality and performance of regulated products departments of Regulatory Affairs
All medicines must meet three criteria: be of
professionals.
good quality, safe and effective. The judgments Regulatory Affairs departments are growing
about medicines quality, safety and efficacy
within companies & is constantly evolving and
should be based on solid science.
growing and is the one which is least impacted
Regulatory Affairs also has a very specific during the Acquisition and Merger, and also
meaning within the healthcare industries
during recession. Global harmonization in
(pharmaceuticals, medical devices, Biologics standards has led to consistent approach in
and functional foods). The success of
regulatory submissions and hence its review.
regulatory strategy depends on interpretation,
application, and communication within/ outside This department is responsible for
the companies. understanding the regulatory requirements for
getting new /Generic products approved. They

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J.K.Badjatya International Journal of Drug Regulatory Affairs; 2013, 1(1), 1-4 ISSN: 2321 - 6794
know the commitments that company has made requirements for registration of products.
to the regulatory agencies where the product Regulatory Affairs professionals, with
going to be approved. They also submit annual knowledge of the Guidelines & regulations, are
reports and supplements to the agencies. frequently called in to advice on such matters.
This profession acts as the interface between
Importance of Drug Regulatory Affairs
the pharmaceutical industry and Drug
Regulatory authorities across the world. In this Global competitive environment the
This department mainly involved in the reduction of the time taken by a product to
registration of the drug products in respective reach the market is critical parameter and
countries prior to their marketing. hence the company’s success relies on that.
It can be of:- The proper control maintain of its Regulatory
• 1. Domestic Regulatory Affairs (DRA) - Affairs activities is therefore of considerable
Country of origin economic importance for the company.
• 2. International Regulatory Affairs (IRA) – Wrong or inadequate reporting of data may
Other than country of origin prevent a timely positive evaluation of a
Regulatory Affairs communicates with one of marketing application. A new drug requires
the Centers e.g., Center for Drug Evaluation many millions of dollars to develop it and even
and Research (CDER) at the FDA a single day delay in bringing it to the market
headquarters, MHRA/ Countries Ministry of has considerable financial considerations. Even
Health (MOH); Regulatory Affairs is a worse, failures to fully report all the required
comparatively new profession which is data or the product release of with incorrect
initiated from governments to protect public labeling, may result in a product recall.
health, by controlling the safety and efficacy of Regulation is a binding instruction issued by an
products in areas including pharmaceuticals, agency that tells how to interpret and comply
veterinary medicines, medical devices, with a law. Failures to follow the regulations
pesticides, agrochemicals, cosmetics and may end up in the “issued warning letter”
complementary medicines. The companies section of the FDA website, which is not a
involved in discovery, testing, manufacture and good for a Pharma company.
marketing of Drug products should ensure that A good Regulatory Affairs professional will
they supply the quality products that are safe & have a ‘right first time’ approach and will play
effective for public health and welfare. Most a very important part in coordinating scientific
Pharma companies have specialist departments Endeavour with regulatory demands
of Regulatory Affairs professionals – and those throughout the life of the product, helping to
who don’t, rely on the expert advice of maximize the cost-effective use of the
independent regulatory consultants to meet company’s resources.
their obligations. The Regulatory Affairs department is the first
The Regulatory Affairs department also takes point of contact between the Ministry of Health
part in the development of the product /Government departments and the company.
marketing concepts and is usually required to The Drug Regulatory Affairs Professional
approve packaging and advertising before it is
used commercially. Their Regulatory Affairs It takes many years for bringing a new drug to
departments must be aware of the regulatory the market; it is therefore essential that the
requirements in all the company’s export process should be managed effectively from
markets. beginning to end in order to meet the
The registration data prepared for one country regulatory requirements and permit a favorable
frequently fail to meet the requirements for evaluation of Quality, efficacy and safety in the
another. Therefore great care has to be taken in shortest possible time. The drug regulatory
drawing up efficient and economical research affairs (DRA) professional plays an important
and development programs whose results may role in each phase of this process, from
be used as widely as possible. Different developing effective regulatory strategies
governments as an international effort are now following the discovery of a new molecule up
trying to harmonize the regulatory to the planning post-marketing activities.

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J.K.Badjatya International Journal of Drug Regulatory Affairs; 2013, 1(1), 1-4 ISSN: 2321 - 6794
The main role of the DRA professional within  Excellent writing and communication skills
a pharmaceutical Industry is to secure approval  Listen actively
of drug submissions from Health Therapeutic  Interpret and consolidate data
Products Program and to ensure regulatory  Strong follow-ups and convincing ability
compliance of marketed and investigational  Technical sound knowledge
drugs with the Food and Drug Act and
Emerging Trends Affecting Regulatory
Regulations and Guidelines/Policies.
Strategy
For this position, the DRA professional must
possess a proficient scientific background and  Strong growth in Emerging Markets
have a thorough knowledge of Domestic  Acquisition and licensing opportunities
regulations as well as international regulations.  Biologics and Biosimilars market
Because the regulatory requirements are expansion
moving towards global and mutual recognition  Aging populations
between different health authorities across the  New product development strategies
world, it is a major challenge for the DRA  Rare diseases
professional to keep & update policy and to  Quality aspects in entire supply chain
determine how these changes in policies affects  ICH expansion
the regulatory approval process. Consequently,  Collaboration among regulatory agencies
the importance of DRA in the development and
approval of new drugs has increased Global Market is divided into:
significantly over the last decade.
The DRA professional must actively 1. Regulated Market: US, EU (UK,
participate in discussions and coordinate team Germany, France, Ireland, Sweden etc.),
activities to obtain all the necessary Japan, Canada, Australia, New Zealand,
documentation and then assess it for South Africa
completeness and accuracy. Therefore, an 2. Semi regulated Market: (ROW
effective DRA professional must exhibit the Countries):
organizational and interpersonal skills of a (a) Asia (Sri Lanka, India, Bangladesh,;
"team player" and also be thorough and detail- ASEAN: 10 Countries group - Philippines,
oriented. Vietnam Singapore, Malaysia, Thailand,
The scope of responsibilities is so wide and Indonesia, Laos, Cambodia, Brunei
may vary significantly according to the Darussalam, Myanmar
organizational structure of the pharmaceutical (b) African countries (Algeria, Zambia,
company. The responsibilities of some DRA Ethiopia, Ghana, Kenya, Malawi,
professionals may focus on Pharmacovigilance Mozambique, Namibia, Nigeria, Sierra
activities or on the electronic representation of Leone, Tanzania, Zimbabwe etc.)
data (electronic submissions). Other (c) Middle East countries (Gulf Co-operation
responsibilities may include product launch Council countries i.e. Bahrain, Kuwait,
activities, DMF submission, formulary Oman, Qatar, Saudi Arabia, UAE)
submissions, review of advertising materials (d) Latin America (Mexico, Brazil, Panama,
and quality assurance. The primary function is Peru, Guatemala, Argentina, Chile,
the liaison between the Ministry of Health & Dominican Republic)
Company. (e) CIS (common wealth of independent
states): Russia, Ukraine, OFSUs (Armenia,
Skills & Attributes required for making a Azerbaijan, Belarus, Georgia, Kazakhstan,
good RA Skills Kirghizstan, Moldova, Tajikistan,
Turkmenistan, Uzbekistan etc.)
 Influence IT Literate
 Work independently Responsibility of Regulatory Affairs
 Persuade Accuracy Professional’s
 An effective negotiator 1. Ensuring that their companies comply with
 Present Quality all of the system policy and laws pertaining to
their business.

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J.K.Badjatya International Journal of Drug Regulatory Affairs; 2013, 1(1), 1-4 ISSN: 2321 - 6794
2. Working with federal, state, and local poor presentation of data. In most product areas
regulatory agencies and staff on specific issues where regulatory requirements are imposed,
distressing their commerce. i.e. working with restrictions are also placed upon the claims
agencies as the Food and Drug Administration which can be made for the product on labeling
or European Medicines Agency or in advertising.
(pharmaceuticals and medical devices)
3. Advising their companies on the regulatory References
aspects and climate that would affect proposed 1. Regulatory Affairs from Wikipedia, the free
actions. i .e. describing the "regulatory climate" encyclopedia modified on 7th April available at
http://en.wikipedia.org/wiki/ Regulatory_ Affairs.
in the region of issues such as the endorsement 2. International regulatory affair updates 2005 available
of prescription drugs. at http://www.iraup.com /about.php
3. “Douglas J Pisano and David S. Mantus” ‘Text book
The Regulatory Affairs professional’s job is to of FDA Regulatory Affairs A Guide for Prescription
keep track of the ever-changing legislation in Drugs, Medical Devices, and Biologics’ Second Edition.
all the countries where company wants to 4. Regulatory Affairs brought by learning plus, inc.
register their products. available at http://www.cgmp .com/ra.htm.
They advice at all stages both in terms of legal 5. Science career brought by American association 2011
available at http:/ /sciencecareers.sciencemag.org
and technical requirements and restrains help /career_magazine/previous_issues/articles/
companies save a lot of time and money in 1999_12_24/no DOI.1 20792759800514086 99.
developing the product and marketing the 6. Topra brought by dimension associates available at
same. http://www.topra.org /care ers/whatregulatory-affairs.
In an organization their prime responsibilities 7. Training Needs in Regulatory Science for the
Biopharmaceutical Industry,” Naturejobs Biotechnology,
involves preparation and presentation of 2001, 19 (12) 1187-1188.
registration documents to regulatory agencies 8. “Careers in Regulatory Affairs from Practitioner to
and carry out all following discussion to obtain professional,” Naturejobs Biotechnology, 2002, 20(4),
and maintain marketing authorization (MA) for 409-410.
the products concerned.
They need to keep a track on ever changing
legislation in all countries where the companies
is looking to market their product.
It may take nearly 15 years to develop and
launch a new pharmaceutical product and many
problems may arise in the process of scientific
development due to changing of regulatory
environment.
Conclusion
DRA is a dynamic, rewarding field that
includes both scientific and legal aspects of
drug development. DRA professionals are
dedicated individuals who take pride in their
contribution to improving the health and
quality of life of peoples.
RA as profession 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.
Regulatory Affairs professionals help the
company avoid problems caused by badly kept
records, inappropriate scientific thinking or

© 2013, IJDRA Publishing Group, All Rights Reserved Page 4