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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Issuance of Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy (Biologicals)

16-May-2024 | NA

Ministry of Health and Family Welfare has issued Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy (Biologicals), effective from 16th May, 2024.

Key Highlights of the Notification are:

1. The manufacturer or sponsor has to submit application in Form CT-04 for permission of Clinical Trial under the provisions of New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetic Act, 1940.
2. Provide name and address of the laboratory or laboratories with accreditation certificate/ Authorization for all animal toxicological reports.
3. Provide details of the statistical approach to be followed including sample size, how the sample size was determined, including assumptions made in making this determination, efficacy endpoints (primary as well as secondary) and safety endpoints.

Please refer to the attached document for more details.

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