From May 10 to 14, 2025, the ICH Assembly was held in Madrid, Spain. During the ICH Assembly, two new topics: E23: Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a focus on Effectiveness of Medicines and M18: Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs were established. Entrusted by IFPMA, the China Pharmaceutical Innovation and Research Development Association (PhIRDA) successfully nominated six experts to join the Expert ICH Working Groups for the two new topics. These experts will  participate in the drafting and revision of related guideline documents.
The six experts are listed below:

As of July 2025, PhIRDA has nominated 69 experts (including 13 Leads and 11 Alternates) to 32 IFPMA ICH Expert Working Groups, accounting for 43% of IFPMA’s global expert pool.

The 2025 ICH Assembly will be held in Singapore from November 15 to 19. During the meeting, 12 working groups will convene. The leads of the M18 and E23 working groups will attend in person to discuss the next steps for these new topics and promote the coordination and harmonization of international regulations.

Click to view PhIRDA IFPMA ICH Expert List