The Assembly of the International Council for Harmonisation (ICH) met in-person on 13 & 14 May 2025, in Madrid, Spain in parallel of meetings of 11 Working Groups, and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee.
The ICH continues to expand and welcomed with great pleasure DINAVISA, Paraguay; MOH, Kuwait; and SRS, El Salvador as new ICH Observers, bringing ICH to a total of 23 Members and 41 Observers.
Mr. Daisuke Koga, MHLW/PMDA, Japan, was also announced as the new ICH MC Vice-Chair, being elected to serve until the end of the next ICH meeting in November 2025 following the mid-term departure of the previous Vice-Chair, Mr. Naoyuki Yasuda, MHLW/PDMA, Japan.
New Areas of ICH Harmonisation
The Assembly adopted four new topics for harmonisation at the Madrid meeting, with the starting timeframe to be determined in a subsequent step:
- “Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a focus on Effectiveness of Medicines” – a new ICH Efficacy Guideline that proposes a systematic approach to using RWE in regulatory decision making;
- “Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs” – a new ICH Multidisciplinary Guideline to address factors to consider in determining the utility of comparative efficacy studies (CES) in biosimilar development programs;…
