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

Issuance of Post Approval Changes in Biological Products: Quality Safety and Efficacy Documents

16-May-2024 | NA

Ministry of Health and Family Welfare has issued Post Approval Changes in Biological Products: Quality Safety and Efficacy Documents, effective from 16th May, 2024.

Key Highlights of the Notification are:

1. Marketing authorization holders should recognize any change to a biological product has a potential impact on the quality, safety and/or efficacy of that product.
2. This document is intended to serve as a guide for post-approval changes to biological products.
3. The objective of this guidelines to provide Marketing Authorization Holders (MA holders) with recommendations on the data to support a change which would be considered sufficient to allow a determination of the impact of the change on the quality of the approved products as it relates to safety, efficacy and/or effective use of the products.
4. This guidance document applies to MA holders intending to make changes to biological products that have received an approval to market the products.
Please refer to the attached document for more details.

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