The Assembly of the International Council for Harmonisation (ICH) met in person on 18-19 November 2025 in Singapore, in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).
ICH is delighted to welcome NAFDAC, Nigeria and SAHPRA, South Africa as new ICH Members, in addition to two new Observers: DIGEMAPS, Dominican Republic and Philippine FDA, Philippines, bringing ICH to a total of 25 Members and 41 Observers.
Elections
The ICH Assembly and Management Committee Chair and Vice-Chair elections were held to serve a two-year term. Swissmedic is very pleased to announce the appointment of Dr. Gabriela Zenhäusern as the new Chair of the ICH Assembly, alongside the following appointments:
- Dr. Gabriela Zenhäusern (Swissmedic, Switzerland) and Mr. Jeffrey Skene (Health Canada, Canada) were elected as Assembly Chair and Vice-Chair respectively;
- Mr. Daisuke Koga (MHLW/PMDA, Japan) and Dr. Theresa Mullin (FDA, United States) were elected as Management Committee Chair and Vice Chair respectively;
Progress on ICH Guideline Development and Important Revisions
Final Guideline adopted at Step 4
The M11 Guideline on Clinical Electronic Structured Harmonized Protocol (CeSHarP), M11 Clinical Implementation Template and M11 Technical Specification were adopted and have now entered the implementation phase. The Guideline describes general protocol design principles and the approach used to develop the separate associated documents, the ICH M11 Clinical Electronic Structured Harmonised Protocol Template and the Technical Specification, which are acceptable to all regulatory authorities of the ICH regions.
The ICH E2D(R1) Guideline on Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports were adopted and have now entered the implementation phase. The guideline provides recommendations that are harmonised to the extent possible given differences in post-market safety reporting requirements among ICH regions.
The ICH M14 Guideline, General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies that Utilise Real-World Data for Safety Assessment of Medicines, was adopted and has now entered the implementation phase. The Guideline provides internationally harmonised recommendations to plan, design, analyse and report non-interventional pharmacoepidemiological studies that generate real-world evidence for post-marketing safety submissions.
Draft Guidelines endorsed at Step 2 a/b
The ICH E22 draft Guideline, General Considerations for Patient Preference Studies, was adopted and entered the public consultation period. This draft guideline outlines general considerations about the use, design, conduct, analysis, and submission of Patient Preference Studies.
The ICH Q3E draft Guideline for Extractables and Leachables and supporting document waere adopted and entered the public consultation period. The draft guideline presents a framework and process for the assessment and control of leachable impurities to further expand the existing ICH guidelines on impurities, including ICH Q3A-D and ICH M7.
The ICH E20 draft Guideline on Adaptive Designs for Clinical Trials was adopted and entered the public consultation period. The draft Guideline provides guidance on confirmatory clinical trials with an adaptive design.
The next ICH Assembly meeting is planned to take place in Rio de Janeiro, Brazil on 2 and 3 June 2026.
Further information can be found in the ICH press release: ICH website
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