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 2024-21559 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on September 20, 2024. 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 FDA is proposing this action because the existing regulations have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary. View the original at https://www.federalregister.gov/documents/2024/09/20/2024-21559/revocation-of-regulations-regarding-the-mutual-recognition-of-pharmaceutical-good-manufacturing.

No. Document 2024-21559 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.