#2026-03286Amerika Birleşik Devletleri ve Avrupa Topluluğu: İlaç İyi Üretim Uygulamaları Raporlarının, Tıbbi Cihaz Kalite Sistemi Denetim Raporlarının ve Belirli Tıbbi Cihaz Ürün Değerlendirme Raporlarının Karşılıklı Tanınmasına İlişkin Yönetmeliklerin İptali
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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. Published in the Federal Register / US official sources.
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Action
Final rule.
Key Changes
- Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evalua
Obligations
What this law requires
Revoke and eliminate compliance with 21 CFR part 26 regulations regarding mutual recognition of pharmaceutical GMP reports, medical device quality system audit reports, and certain medical device product evaluation reports between the US and European Community
Cease reliance on the revoked mutual recognition regulations (21 CFR part 26) as a basis for regulatory acceptance of audit reports and evaluation reports
Transition compliance framework from revoked 21 CFR part 26 to the United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs) that entered into force in 2017