Data / Federal rules / 2024-21559
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community
The Food and Drug Administration published this proposed rule in the Federal Register on September 20, 2024. Comments closed on November 19, 2024.
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What the agency says
The Food and Drug Administration (FDA, Agency, or we) is proposing to revoke the regulations entitled "Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community." FDA is proposing this action because the existing regulations have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.
Key facts
- Document number
- 2024-21559
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 20, 2024
- Comments due
- November 19, 2024
- Dates
- Either electronic or written comments on the proposed rule must be submitted by November 19, 2024.
- Docket
- Docket No. FDA-2024-N-4016
- Regulation ID (RIN)
- 0910-AI92
- Code of Federal Regulations
- 21 CFR 26
- Topics
- Animal drugs; Animals; Biologics; Drugs; Exports; Imports
- Pages
- 4
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Everything from the Food and Drug Administration · Rules on animal drugs · Rules on animals · Rules on biologics · Published in September 2024
Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.