Mr. Dipak B.

Bhingardeve
Assistant Professor
Department of Pharmaceutics
 Regulatory Affairs (RA) is a profession within the
health care industry namely, Pharmaceutical, Medical
Device, Biologics, & Functional Food.

 Regulatory Affairs is a 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.
 RA profession at its heart is all about Collecting,
Analyzing and Communicating the Risks and Benefits of
health care products to regulatory agencies and public
all over the world.

 Regulatory Affairs (RA), also called Government

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

 This department is responsible for understanding the

regulatory requirements for getting new /Generic
products approved.
 They know the commitments that company has made
to the regulatory agencies where the product going to
be approved. They also submit annual reports and
supplements to the agencies.

 Drug Regulatory Affairs is a function which regulates

the pharmaceutical science in order to facilitate
trade / business in and outside the country of origin
for public interest.
 During 1950’s, many tragedies happened due to the
misjudgement of the personnel during manufacture
and some intentional addition of adulteration of
substances into the pharmaceutical product which has
lead to the death of the patients.

 After so many incidents, the regulatory bodies

introduced the new laws and guidelines which improve
the quality, safety and efficacy of the products
 Due to rapid increase in laws, regulations and guidelines
for reporting safety, efficacy and quality of new
medicinal products, necessity for expert regulatory
professional arises tremendously.

 None of the drug manufacturing / marketing units are

able to launch drug in market until and unless
respective health authority (national / international)
give green signal in writing.

 Without fulfilling requirements of law of land, it is

practically impossible to have drug products in market.
 Almost two decades before, drug regulatory affairs was
least known / needed by pharmaceutical industry.

 It was in very nascent stage where registration

executives were working under export department.

 However, the situation has changed drastically where

fully fledged Global Regulatory Affairs department
become mandatory to define drug development,
approval and marketing strategy.

 Hence, the scope of Drug regulatory affairs has

become vast and experts are needed in health
authorities and pharmaceutical industry at various
levels and departments.
 At the same time, the regulation pertaining to
pharmacovigilance requirements mandates
companies to monitor new drugs safety aspects
throughout the life cycle of product.

 In this scenario, the role of regulatory expert is very

critical and important for deciding the entry strategy
into various national and international markets.
 1. Ensuring that their companies comply with all of the
system policy and laws pertaining to their business.

 2. Working with federal, state, and local regulatory

agencies and working with agencies as the Food and
Drug Administration or European Medicines Agency
(pharmaceuticals and medical devices).

 3. Advising their companies on the regulatory aspects

and climate that would affect proposed actions. i .e.
describing the "regulatory climate“ in the region of
issues such as the endorsement of prescription drugs.
 Evaluation of Marketing Authorization Application
i.e. New Drugs Application, New Biologics Application,
Medical Device and Cosmetics application, Generic
Application, Clinical Trial Application, Variation
Application, Drug Master Files for API, Excipients and
Packaging Materials, Site Master File for GMP inspection.
 Support to Pharmaceutical Manufacturers:

 1.Supporting Manufacturer in defining drug

development pathway during Pre-NDA meeting and
providing comments / confirming development pathway.

 2.Time to time meeting with pharmaceutical

manufacturers association to discuss ongoing
challenges, technical issues, guidelines/ guidance
documents discussion and future development
 Monitoring of Drug Safety and Efficacy:

 1. Monitoring Drug Safety by collecting

Pharmacovigilance data and reviewing drugs in markets
time to time by reviewing labels and taking appropriate
action accordingly.

 2. Monitoring Clinical Trials as well as approving study

results for next phase of study .
 Regulatory systems and processes:

 1. Keeping records for Drug Product Submission and

Approval database

 2. Preparing Standard Operating Procedure (SOP) for

efficient management of drug regulatory affairs
department

 3. Be part of Regulatory forums/ conferences/

webinars / seminars to exchange regulatory knowledge
 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.
 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.
 Regulatory bodies such as the Food and Drugs
Administration (FDA) in the USA are responsible for
approving whether a drug can proceed to clinical trials
and whether it should be allowed to come in to the
market or not.

 These body has to evaluate the scientific and clinical

data to ensure that the drug can be produced with
consistently high purity, better therapeutic results and
it does not have unaccepted side effects.

 It must also approve the labeling of the drug and the
directions for its use or we can say regulatory body has
taken interested in all aspects of a drug designing and
its formulatation.
 Country Regulatory Body

 USA Food and Drug Administration (FDA)

 UK Medicines and Healthcare Products
Regulatory Agency (MHRA)
 Australia Therapeutic Goods Administration (TGA)

 India Central Drug Standard Control

Organization (CDSCO)
 Canada Health Canada
 Europe European Medicines Agency (EMEA)
 Japan Ministry of Health, Labour &
Welfare(MHLW)
 Challenges
The major challenges of these regulatory bodies are

* To promote public health and protect the public from

harmful and dubious drugs,

* To establish proper legalization covering all products

with a medicinal claim and all relevant pharmaceutical
activities, whether carried out by the public or the
private sector.

* To increase worldwide regulatory growth to ensure

safety of people.
 Conclusion:

Regulatory agencies and organizations around the world

need to ensure the safety, quality and efficacy of
medicines and medical devices, harmonization of legal
procedures related to drug development, monitoring
and ensuring compliance with statutory obligations.
However the need of the hour is

* More centralized procedures in drug regulation

* Harmonization of regulatory norms
* Strengthening the regulatory authorities
 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.

 The main responsibility of the DRA professional within a

pharmaceutical company is to secure approval of drug
submissions from Health Therapeutic Products Program
(TPP) and to ensure regulatory compliance of marketed
and investigational drugs with the Food and Drug Act
and Regulations and TPP Guidelines/Policies.
 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 regulations as
well as international regulations.

 They are responsible for the presentation of

registration documents to regulatory agencies, and
carry out all the subsequent negotiations necessary to
obtain and maintain marketing authorization for the
products concerned. 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.

 It also helps the company to avoid problems caused by

badly kept records, in appropriate scientific thinking
or poor presentation of data.
 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.