Data / Federal rules / 2026-03286
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 final rule in the Federal Register on February 19, 2026. It took effect on March 23, 2026.
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What the agency says
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule revoking 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 FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.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
- 2026-03286
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- February 19, 2026
- Takes effect
- March 23, 2026
- Dates
- This rule is effective March 23, 2026.
- 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
- 5
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Everything from the Food and Drug Administration · Rules on animal drugs · Rules on animals · Rules on biologics · Published in February 2026
Read from the Federal Register API, last updated 2026-10-23. 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.