Regulatory aspects of clinical trials refer to the rules, regulations, and guidelines set forth by regulatory agencies that govern the design, conduct, and reporting of clinical trials. These regulations are put in place to ensure the safety and well-being of study participants and to ensure that the results of the study are accurate and reliable. In the United States, the Food and Drug Administration (FDA) is the primary regulatory agency responsible for overseeing the conduct of clinical trials. The FDA sets forth guidelines and regulations for the design, conduct, and reporting of clinical trials to ensure that they are conducted in a safe, ethical, and scientifically sound manner. Some of the key regulatory aspects of clinical trials include: Study design: Regulatory agencies require that clinical trials be designed in a manner that ensures the safety of study participants and that the results of the study are scientifically valid. Informed consent: Study participants must provide informed consent prior to participating in a clinical trial. This means that they must be fully informed of the risks and benefits of the study and must provide their voluntary consent to participate. Investigational products: Investigational products, such as new drugs or medical devices, must be approved by regulatory agencies prior to being used in a clinical trial. Additionally, the use of these products must be closely monitored and reported to regulatory agencies. Data reporting: The results of clinical trials must be reported to regulatory agencies in a timely and accurate manner. This includes reporting adverse events or unexpected outcomes.

1. Welcome
REGULATORY ASPECTS OF CLINICAL TRIALS
Atika Siddiqua
PharmD
CSRPL_STD_IND_HYD_ONL/
CLS_011/012023
atika.sid5@gmail.com
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1

2. Index
1. Regulatory environment in
India
2. Regulatory environment in
USA
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(3 – 8)
(9 - 14)

3. Regulatory Environment in India:
• The principal regulatory body involved in approval of 'manufacture, development and manufacture of
drugs' is CDSCO.
• The Central Drug Standard Control Organization (CDSCO) is the main regulator body of India for
regulation of pharmaceutical drugs, medical devices and Clinical Trials.
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GOVT. OF INDIA
Ministry of Health
and Family Welfare
Ministry of
Chemicals and
Fertilizers
Ministry of
Commerce
Ministry of Science
and Technology
DGHS
CDSCO
DCGI DTAB
Department of
Pharmaceuticals
Patent Office
Controller general of
Patents
NPPA
ICMR
DBT
CSIR Labs
India: Well-defined Drug Regulatory System

4. Regulatory Bodies
in India:
• Drug Controller General of India (DCGI)
• Indian Council of Medical Research (ICMR)
• Drugs Consultative Committee (DCC)
• Central Drugs Laboratory (CDL)
• Drugs Technical Advisory Board (DTAB)
• Central License Approval Authority (CLAA)
• National Pharmaceutical Pricing Authority
(NPPA)
• Department of Biotechnology (DBT)
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6. Organization of CDSCO
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*The current DCGI is Dr. Rajeev Singh Raghuvanshi

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Drug Approval Process in India

9. Regulatory Environment in USA:
• The US FDA is a scientific, regulatory and public health agency responsible for regulating and supervising
the safety and of most of the food products, human and animal drugs, therapeutic agents of biological
origin, medical devices and cosmetics.
FDA Background:
• The United States Department of Agriculture and the Division of Chemistry was established in the year
1867.
• In the year 1927, the Division of Chemistry was divided into regulatory and non-regulatory departments.
• The regulatory department was responsible for food, drugs, insecticides, cosmetics and fertilizers.
• The non-regulatory department included Bureau of Chemistry and Soils.
• In the year 1930, the food, drugs, insecticides, cosmetics and fertilizers Act was changed into the Food
and Drugs Administrative Act (FDA).
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10. FDA Divisions:
1. Center for Tobacco products
2. Center for Drug Evaluation and Research (CDER)
3. Center for Biological Evaluation and Research (CBER)
4. Center for Food safety and Applied Nutrition
5. Center for Devices and Radiological Health (CDRH)
6. Center for Veterinary medicine (CVM)
7. National Center for Toxicological Research (NCTR)
8. The Office of regulatory affairs
9. The office of Commissioners
Code of Federal Regulations (CFR):
All of the guidelines in the USA, are given by the Code of Federal Regulations (CFR).
• 21 CFR Part 11 – Electronic Records and Electronic signatures
• 21 CFR Part 312 – IND Application
• 21 CFR Part 314 – NDA & ANDA Application
• 21 CFR Part 316 – Orphan drugs
• 21 CFR Part 201 – Drug labelling
• 21 CFR Part 54 – Financial disclosures by sponsors
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11. FDA Organizational Chart
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Drug Approval Process in the USA (INDA)

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Drug Approval Process in the USA (ANDA)

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Drug Approval Process in the USA (NDA)

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Atika Siddiqua
PharmD
CSRPL_STD_IND_HYD_ONL/
CLS_011/012023
atika.sid5@gmail.com