International Council for Harmonisation (ICH) Assembly Welcomes New Members and Observers

2nd December 2025

International Council for Harmonisation (ICH) Assembly Welcomes New Members and Observers

Summary: At its 18–19 November 2025 meeting in Singapore, ICH welcomed NAFDAC (Nigeria) and SAHPRA (South Africa) as full new Members, and added DIGEMAPS (Dominican Republic) and Philippine FDA (Philippines) as new Observers — raising ICH’s total to 25 Members and 41 Observers worldwide. 
During the same meeting, the Assembly adopted several important regulatory updates, including:

• Final adoption (Step 4) of the ICH M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP), which establishes a standardised electronic format for clinical trial protocols. 

• Final adoption (Step 4) of the ICH E2D (R1) guideline on post-approval safety data reporting and the ICH M14 Guideline on Pharmacoepidemiological Studies using Real‑World Data, enhancing global harmonisation of safety monitoring and real-world evidence generation. 

Link: ICH Assembly Welcomes New Members and Observers at ICH51

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