GMP topical

04.04.2025

China: Draft Revision of GMP Annex for Sterile Drugs

The Chinese drug authority NMPA has published its long-awaited draft annex to the Chinese GMP for sterile drugs for public review and comment. There is close alignment with the tripartite WHO/EU/PICs GMP Annex that was published in 2022.

Unfortunately, there is no "official" English translation yet.

The NMPA invites comments until 30 May 2025.

Source:

NMPA: Draft Revision of GMP Annex for Sterile Drugs (2025) (3/17/2025)

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