ICH: Assembly Meeting 2025

28.11.2025

News

The ICH Assembly met on 18–19 November 2025 in Singapore and welcomed NAFDAC (Nigeria) and SAHPRA (South Africa) as new members, along with two new observers. Elections were held for leadership roles across the Assembly, Management Committee, and MedDRA Steering Committee.

Several major guidelines reached Step 4, including:

M11 CeSHarP (harmonized electronic clinical protocol)
E2D(R1) on post-approval safety data reporting
M14 on RWD-based pharmacoepidemiology studies

Three important draft guidelines entered Step 2b public consultation:

E22 (Patient Preference Studies)
Q3E (Extractables & Leachables)
E20 (Adaptive Clinical Trial Designs)

MedDRA is now available in 27 languages, and the new LMS shows strong uptake. ICH also introduced a new training strategy, including the use of AI tools.

Five experts received the ICH Award 2025 for outstanding contributions. To mark 35 years of ICH, a new communication campaign and an official LinkedIn account were launched. The next Assembly meeting will take place in June 2026 in Rio de Janeiro.

Source:

ICH: Press release, ICH Assembly Meeting, Singapore, November 2025

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