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ICH M13A (EMA, FDA, HC) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2025-10-18 14:24 (228 d 18:50 ago) – Posting: # 24467
Views: 1,870

Hi John,

❝ Does anyone know if the following guideline from ICH M13a (Final, July 2024) has been officially adopted by EMEA, FDA and Health Canada?

Yes, though the EMEA was rebranded to EMA in 2004. :-D

EMA: Implemented 25 July 2024, effective with 25 January 2025
FDA: October 2024
HC : Will be implemented on 27 December 2025

Complete thread:

New ICH M13a guidance on BE analysis jag009 2025-10-17 21:04
- ICH M13A (EMA, FDA, HC)Helmut 2025-10-18 12:24

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