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1. Regulatory bodies for clinical
research and development in five
different countries
-by
Tushar kumar Sah
Enroll-0845PY201101
B.pharm,5th semester,3rd year

2. 1) INDIA
 The regulatory body for clinical research in India is – Drugs Controller
General of India (DCGI).
 Drugs Controller General of India (DCGI) is the head of department of
the Central Drugs Standard Control Organization of the Government of
India responsible for approval of licences of specified categories
of drugs such as blood and blood products, IV fluids, vaccines, and sera
in India. Drugs Controller General of India, comes under the Ministry of
Health & Family Welfare.[1] DCGI also sets standards for manufacturing,
sales, import, and distribution of drugs in India.
 Its headquarter is situated in New Delhi.
 Venugopal Girdharilal Somani, the drug controller general of India
(DCGI) since July 2019.

3. 2) United States of America:-
 As per the FDCAct, 21CFR50, and 21CFR312, the Food & Drug
Administration (FDA) is the regulatory authority that regulates clinical
investigations of medical products in the United States (US).
 The United States Food and Drug Administration (FDA or USFDA) is
a federal agency of the Department of Health and Human Services. The
FDA is responsible for protecting and promoting public health through the
control and supervision of food safety, tobacco products, dietary
supplements, prescription and over-the-counter pharmaceutical
drugs (medications), vaccines, biopharmaceuticals, blood
transfusions, medical devices, electromagnetic radiation emitting devices ,
cosmetics, animal foods & feed and veterinary products.
 FDA headquarters facilities are currently located in Montgomery
County and Prince George's County, Maryland.
 Robert M. Califf is Commissioner of Food and Drugs. President Joe Biden
nominated Dr. Califf to head the U.S. Food and Drug Administration.

4. 3) Canada:-
 The regulatory body for clinical research in Canada is – Health
Canada(HC).
 Health Canada is the department of the Government of
Canada responsible for national health policy. The department itself is also
responsible for numerous federal health-related agencies, including
the Canadian Food Inspection Agency (CFIA) and the Public Health
Agency of Canada (PHAC), among others. These organizations help to
ensure compliance with federal law in a variety of healthcare, agricultural,
and pharmaceutical activities.
 FDA headquarters facilities are currently located in Montgomery
County and Prince George's County, Maryland.
 Health Canada (HC) headquarters facilities are currently located in Ottawa,
Ontario, Canada.
 The third and current chief public health officer of Canada is Theresa Tam,
who was appointed in June 2017.

5. 4) Japan:-
 PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese
regulatory agency, working together with Ministry of Health, Labour and
Welfare to regulate clinical trial in japan
 PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese
regulatory agency, working together with Ministry of Health, Labour and
Welfare.
Our obligation is to protect the public health by assuring safety, efficacy and
quality of pharmaceuticals and medical devices.
We conduct scientific reviews of marketing authorization application of
pharmaceuticals and medical devices, monitoring of their post-marketing
safety. We are also responsible for providing relief compensation for
sufferers from adverse drug reaction and infections by pharmaceuticals or
biological products.
 Dr. Tatsuya Kondo is currently the Chief Executive of Pharmaceuticals and
Medical Devices Agency (PMDA).
 The headquarter of PMDA is situated in Tokyo, Japan.

6. 5) Europe:-
 The European Medicines Agency (EMA) is an agency of the European
Union (EU) in charge of the evaluation and supervision of medicinal
products. Prior to 2004, it was known as the European Agency for the
Evaluation of Medicinal Products or European Medicines Evaluation
Agency (EMEA).
 The EMA operates as a decentralised scientific agency of the European
Union and its main responsibility is the protection and promotion of public
and animal health, through the evaluation and supervision of medicines for
human and veterinary use. More specifically, it coordinates the evaluation
and monitoring of centrally authorised products and national referrals,
develops technical guidance and provides scientific advice to sponsors. Its
scope of operations is medicinal products for human and veterinary use
including biologics and advanced therapies, and herbal medicinal products.
 The Headquarter of European Medicines Agency (EMA) is located in
the Zuidas district in south Amsterdam.
 The European Medicines Agency's (EMA) Executive Director is Ms Emer
Cooke. Emer Cooke began her mandate as Executive Director of EMA on
16 November 2020.