ICH Assembly Meeting, Singapore — November 2025

2nd December 2025

ICH Assembly Meeting, Singapore — November 2025

Summary: At the 18–19 November 2025 meeting, ICH welcomed two new full members — NAFDAC (Nigeria) and SAHPRA (South Africa) — along with two new observers: DIGEMAPS (Dominican Republic) and Philippine FDA (Philippines), bringing its total to 25 Members and 41 Observers. 

Key guideline milestones achieved:

• The final version (Step 4) of ICH M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) was adopted — a harmonised electronic template that standardises clinical trial protocols for more consistent and interoperable submissions. 

• Final adoption was also given to ICH E2D (R1) Guideline on Post-Approval Safety Data Reporting and ICH M14 Guideline on Pharmacoepidemiological Studies Using Real‑World Data, strengthening global standards for safety reporting and real-world evidence gathering. 

• Several new draft guidelines entered public consultation (Step 2b), including: ICH E22 Guideline on Patient Preference Studies, ICH Q3E Guideline on Extractables and Leachables, and ICH E20 Guideline on Adaptive Clinical Trial Designs — signalling expansion into new topic areas such as patient-centred drug development, product safety, and flexible trial design. 

In addition, ICH updated its leadership: new Chairs and Vice-Chairs were elected for the Assembly, Management Committee and its medical terminology body. 

Link: Press Release: ICH Assembly Meeting, Singapore, November 2025

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