ICH: Assembly Meeting in Japan 2024 Recap
The International Council for Harmonisation (ICH) held its Assembly on 4-5 June 2024 in Fukuoka, Japan, alongside meetings of 13 Working Groups, the ICH Management Committee, and the MedDRA Management Committee. ICH welcomed new members ANMAT (Argentina) and JFDA (Jordan), expanding to 23 Members and 35 Observers.
New Areas of ICH Harmonisation: The Assembly adopted
an Addendum to Guideline M7 for controlling DNA reactive impurities,
particularly nitrosamines, and endorsed a revised Reflection Paper on
using Real-World Data for generating Real-World Evidence.
Progress on ICH Guideline Development Significant updates included:
- ICH M12 Guideline on Drug Interaction Studies: Finalised with supporting Q&As for harmonising drug interaction assessments.
- ICH M14 Draft Guideline: Endorsed for pharmacoepidemiological studies using Real-World Data.
- ICH E2D(R1) Draft Guideline: Endorsed for post-approval safety data management and reporting.
Other Developments
- Approval of the Concept Paper for ICH E22 on Patient Preference Studies.
- Revision of ICH Q4B(R1) for pharmacopoeial text evaluation, now maintained by the Pharmacopoeial Discussion Group (PDG).
- Survey results on ICH Guideline implementation showed progress made by regulatory authorities in implementing ICH Guidelines, with a summary to be published.
MedDRA and Training: MedDRA now has over 8,600 user organisations, with 193 training sessions conducted in 2023. A Finnish translation was added, making MedDRA available in 21 languages. Updated training materials for Q8/Q9/Q10 on Quality Risk Management will be published on the ICH website.
Source:
ICH: Press Release
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