ICH: Assembly Meeting 2025

The International Council for Harmonisation (ICH) held its Assembly meeting on 13–14 May 2025 in Madrid, Spain, alongside 11 Working Groups and prior meetings of the Management and MedDRA Steering Committees.

Membership Updates
ICH welcomed three new Observers: DINAVISA (Paraguay), MOH (Kuwait), and SRS (El Salvador), bringing the total to 23 Members and 41 Observers. Mr. Daisuke Koga (MHLW/PMDA, Japan) was elected as the new Vice-Chair of the ICH Management Committee.

New Harmonisation Topics
Four new topics were adopted for future guideline development:

• Use of Real-World Evidence for regulatory decisions
• Utility of Comparative Efficacy Studies in biosimilar development
• Natural History Studies and Registry Data in rare disease drug development
• Comparability of ATMPs following manufacturing changes (Annex to ICH Q5E)

Guideline Progress and Milestones
The Assembly acknowledged progress on several guidelines:

• Finalised (Step 4):
  • ICH E6(R3): Revised “Good Clinical Practice” guideline adopted in January 2025
• New Drafts Endorsed (Step 2):
  • ICH M4Q(R2): Updated Common Technical Document (CTD) for pharmaceutical registration.
  • ICH E21: Inclusion of pregnant and breastfeeding individuals in clinical trials.
  • ICH Q1: Stability testing of drug substances and products.
  • ICH M13B: Biowaivers for additional strengths of immediate-release solid oral dosage forms in bioequivalence studies
  • ICH M11: Updated Technical Specification for the electronic protocol standard (CESHARP).
  • ICH M7 Addendum: Framework for assessment and control of DNA-reactive impurities, including nitrosamines.

MedDRA Updates
New MedDRA Steering Committee appointments: NMPA (China), SFDA (Saudi Arabia), and IFPMA (Standing Observer). MedDRA is now used by over 9,000 organizations in 141 countries and available in 24 languages, including Icelandic. The MedDRA LMS, launched in early 2025, offers structured online training.

Next Meeting
The next ICH Assembly will take place on 18–19 November 2025 in Singapore.

Source:

ICH: Press Release