Drug regulatory affairs - 1

Regulatory Affairs
By:-
Tanuja Bisht
Associate Professor
Dehradun, Uttarakhand

Contents
 Introduction
 Historical overview
 Regulatory authorities
 Role of Regulatory affair department
 Responsibility of Regulatory Affair Professionals
 Scope of Regulatory Affair Professionals in Industries

Introduction
 Definitions:-
 Regulation: it includes variety of texts (e.g, guidelines, recommendations,
procedures, policies etc) that have different legal bases and authority.
 Drug Regulation: It is the control of drug use by international agreement/
regulatory authorities.
 Pharmaceutical Regulations: defined as combination of legal administrative and
technical measures that government takes to ensure the safety, efficacy and
quality of medicines, as well as, the relevance and accuracy of product
information.
 Regulatory Affairs: regulatory affairs typically refers to that group of scientists
who formulate the strategy for interacting with regulatory authorities in various
countries as well as tactics of securing responses to questions dealing with
submissions and maintaining communication post registration.

 Regulatory Body: It is a public organization or government agency that is a set up to
exercise a regulatory function. This involves imposing requirements, conditions or
restrictions, setting the standard for activities, and enforcing in these areas or obtaining
compliance.
 Regulatory Authorities: it is an autonomous authority or agency established by a federal,
state or provincial government.

 Regulatory affairs (RA) professionals play a crucial role in pharmaceutical industry
and they provides strategic, tactical and operational direction and support to work
within regulations so as to accelerate product development and provide safe and
effective healthcare products or drugs to people around the world.
 RA also known as Govt. Affairs, is a profession within regulated sectors such as
pharmaceuticals, medical devices, energy and banks.

Objectives of RA:
 Provide strategic and technical advice to R&D, production and quality control dept.
 File products in different markets.
 Helps in getting approval from the regulatory bodies.
 Tracks changes in legislation in the regions where the company distributes its
products.
 Interpret and apply regulations.
 Develop and implement regulatory strategies.
 Collect, collate and evaluate scientific data.
 Improve performance of existing functions or activities through regulatory affairs
personnel
 Share training resources where possible and use systematic approach to training.
 Provide advice to internal colleague on legal and scientific requirements.

Need for RA:
 Drugs are meant for improving public health, therefore, their development, manufacture,
importation, subsequent handling and uses require specialized knowledge and skills and
should conform to prescribed standards to strictly maintain their quality.
 Poor regulation can lead to release of standards, counterfeit, harmful and ineffective drugs
to national and international markets resulting in serious harm to health of consumers.
 Main need is to provide the basis for assurance of high quality of drug products, which
can increase consumer’s interest for ensuring the efficacy, quality and safety.

R
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a
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o
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y
A
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f
a
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r
s
Unapproved Product
Investigational
exceptions
Initials
Amendments
Annual reports
Lot release
Adverse events
Approval application
Approval product
Changes
Annual reports
License update
Review meeting
communication
Inspection
Review meeting
communication
RegulatoryAuthority
Quality assurance
Management
License
Product development
Suppliers
Clinical manufacturing
Licensors
Customers
Marketing
Legal
Spectrum Of Regulatory Affairs

Historical overview of RA:
 In the era of 1950s, multiple tragedies resulted in substantial increase of
legislations and their strict implementation to maintain drug product quality, safety
and efficacy.
 Some incidences are given as follows:
 Diphtheria Act led to 1902 Biologics Control Act
 Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act.
 Elixir of Sulfonamide led to the 1938 Food Drug and Cosmetic Act.
 Thalidomide led to the 1962 Kefauver- Harris Amendment.
 Dalkon Shield led to the 1976 Medical Device Amendment.
 Bjork- Shiley Heart Valves led to 1990 Safe Medical Devices Act.

India
 Till 20th century, most of the drugs were imported from other countries.
 After First World War, with the increase in the demand of the drugs, channels opened for
the substandard drug products in the market. To cope this situation, several regulations
were made time to time.
a. In the Era of 1900-1960:
 Poisons Act 1919: to control cheap drugs and their flow in the market, possession of
substance specified as poison and their sale. Also describe safe storage of poisons,
labelling and packaging of the poisons, max quantity to be sold and the inspection &
examination of the poison sold by the seller in entire year.
 Dangerous Drugs Act 1930: to regulate cultivation, manufacture, possession, import,
export and sale of opium and its plants.
 Drugs and Cosmetics Act 1940: to regulate the import, production, distribution and
of drugs.

 Pharmacy Act 1948: this law was amended lastly in 1986 and regulates the pharmacy
profession in India.
 Drugs and Magic remedies (Objectionable Advertisements) Rules 1955: to control the
advertisement of drugs in India.
 Drug Price Control Order (DPCO)1955: to review and fix maximum sale price for
formulations as well as bulk drugs. It was lastly amended in 1995.
b. In the Era of 1960-1990:
 Indian pharmaceutical industries were in initial growth stage, due to dependency on
import, lack of R&D activities and existence of MNC’s in market.
 Indian Patent Act 1970: to protect patent in India. Under this only the process and
manufacturing method of pharmacological substance obtained the patent. The product
patent was not allowed under this law. It replaced the Indian Patent and Design Act of
1911.
 Narcotics and Psychotropic Substances Act 1985: issued to regulate the operation of
narcotic drugs and substances and revoked the Dangerous Drug Act 1930.

c. After the Era of 1990:
 Rapid expansion and globalization of Indian pharmaceutical industry was
in this time period.
 Paris cooperation Treaty 1999: India joined Paris Cooperation Treaty (PCT) in
1999,so as to protect Industrial property and patent rights in each of
contracting state and implemented product patent effective from 1st Jan
 Patent Amendment Act 2005: The Patent (Amendment) Act 2005 defines
invention and clears about existing knowledge or thing cannot be patented.
Herbal preparations having medicinal values can be patented under new
amended law.
 Drugs and Cosmetics (First Amendment) Rules, 2011: mandate the
of clinical research organization (CRO) to conduct clinical trials. Schedule Y1
D&C Act suggests the requirements and guidelines for registration of CRO.

Regulatory Authorities:
 Any autonomous authority or agency established by a federal, state or provincial
government is known as regulatory authority.
 Are established to enforce regulations on development and marketing of drug product
and also regarding occupational health and safety.
Country Regulatory Authority
USA United States Food And Drug Administration (USFDA)
UK Medicine And Healthcare Product Regulatory Agency
Australia Therapeutic Goods Administration (TGA)
India Central Drug Standard Control Organization (CDSCO)
Europe European Medicines Evaluation Agency (EMEA)

 International organizations
 World health organization (WHO)
 World trade organization (WTO)
 International conference on Harmonization (ICH)
 World intellectual property organization (WIPO)
 These regulatory agencies and organizations play an important role in all aspects of
pharmaceutical regulations relating to the registration, production, distribution, price control,
marketing, research and development of pharmaceutical products and intellectual property
protection.
 The main challenges are ensuring safety, quality and efficacy of medicines and medical
devices, harmonization of legal procedures regarding development of medicines, control and
compliance with legal obligations.

ROLE OF REGULATORY AFFAIR DEPARTMENT
DRA
Department
Quality
Assurance
Licensing
Product Development
Supplies and
Suppliers
Clinical Trials
Marketing
Manufacturing
Quality
control &
R&D

 Role of RA Department:
 It is a unique combination of science and management.
 Success of regulatory strategy depends less on regulation than on the way in which they are
interpreted, applied, communicated within companies and to external components.
 It is a first point of contact between government authorities and company and helps in
knowing, implementing and getting approval of these regulations laid down by various
authorities and performs many functions in pharmaceutical industries.

 RA in Product Management:
 Product registration and provide advice to companies both strategically and technically.
 Role starts from product development to production, marketing and post-marketing strategies
and their advice at all stages, both in terms of legal and technical requirements.
 For countries not having their own regulatory bodies and regulations, the guidelines of WHO on
Health and WTO on trade regulations are followed.
 Also the RA officer makes sure that labelling and packaging is done according to the proper
guidelines given by regulation authority.
 RA in Clinical Trials:
 Develop strategies to overcome delays and submit the results of clinical trials to regulatory
agencies for quick authorization, reducing approval time for new molecules.
 Also facilitates collection, analysis and communication of the risks and benefits of healthcare
products for regulatory agencies, healthcare and medical system and the public.
 Also responsible for ensuring that market driven demands, government obligations and evolving
scientific conventions are understood clearly and addressed by multiple stakeholders.

 RA in R&D:
 RA department work together with marketing and research & development to develop novel
product by taking advantage of new technological and regulatory developments to accelerates time
to market.
 The use of adaptive clinical trial strategies, obtaining rapid regulatory approval and eliminating
process difficulties can fasten the development of new products and helps in reducing costly errors
and delays.
 RA in QA & QC:
 RA department in collaboration with QC department submit dossier containing the collected
certificate of analysis, stability studies, analytical method validation reports and protocol for
registration of the product.
 Collects Master Formula Records, process validation protocol, process validation report from QA
dept and reviews them before submitting the dossier to regulatory authorities so as to get
marketing approval or register the product.

 RA in Licensing:
 RA dept using its thorough knowledge and links with government or regulatory bodies
make the path easy to get license.
 RA dept also take care of documentation part to get permission from from concerned
authorities.
 RA in Gathering Information:
 RA dept gathers and maintains information collected from regulators, expertise in drug
development, colleague.
 RA uses this collected information on timely basis in order to ensure the compliance of
regulatory standards for production of safe and effective medicines and betterment of
company.

Drug regulatory affairs - 1

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