Regulatory Aspects of Clinical Trials

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 [email protected] 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index Regulatory environment in India Regulatory environment in USA 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 2 (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.  2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 3 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) 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 4

5. 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 5

6. Organization of CDSCO 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 6 *The current DCGI is Dr. Rajeev Singh Raghuvanshi

7. 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 7

8. www.clinosol.com | follow us on social media @clinosolresearch 2/4/2023 8 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). 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 9

10. FDA Divisions: Center for Tobacco products Center for Drug Evaluation and Research (CDER) Center for Biological Evaluation and Research (CBER) Center for Food safety and Applied Nutrition Center for Devices and Radiological Health (CDRH) Center for Veterinary medicine (CVM) National Center for Toxicological Research (NCTR) The Office of regulatory affairs 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 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 10

11. FDA Organizational Chart 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 11

12. www.clinosol.com | follow us on social media @clinosolresearch 2/4/2023 12 Drug Approval Process in the USA (INDA)

13. www.clinosol.com | follow us on social media @clinosolresearch 2/4/2023 13 Drug Approval Process in the USA (ANDA)

14. www.clinosol.com | follow us on social media @clinosolresearch 2/4/2023 14 Drug Approval Process in the USA (NDA)

15. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 2/4/2023 www.clinosol.com | follow us on social media @clinosolresearch 15 Atika Siddiqua PharmD CSRPL_STD_IND_HYD_ONL/ CLS_011/012023 [email protected]