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

Document 2026-03286 is a Final Rule published by the Department of Health and Human Services in the Federal Register on February 19, 2026, with an effective date of March 23, 2026. 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 FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary. View the original at https://www.federalregister.gov/documents/2026/02/19/2026-03286/revocation-of-regulations-regarding-the-mutual-recognition-of-pharmaceutical-good-manufacturing.

No. Document 2026-03286 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.