From May 10 to 14, 2025, the ICH Meeting was held in Madrid, Spain. During the ICH Meeting, it was decided to establish the Expert Working Group for the new topic ICH Q5E Annex: Comparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their Manufacturing Process. Entrusted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), China Pharmaceutical Innovation and Research Development Association (PhIRDA) has successfully nominated three experts to join the IFPMA ICH Q5E Annex Task Force. These experts will be deeply engaged in the drafting and revision of the guideline, making significant contributions to the harmonization of international regulations. Among them, Dr. ZHANG Lei from BeOne Medicine has been appointed as the Alternate of the Task Force.

The focus of ICH Q5E Annex is to address the challenges of comparability of ATMPs before and after manufacturing process changes, and to establish a globally unified regulatory framework for these innovative medicinal products. The three experts joining the IFPMA ICH Q5E Annex Task Force are listed below:

As of January 2026, PhIRDA has nominated 72 experts (including 13 Leads and 11 Alternates) to 33 IFPMA ICH Task Forces, accounting for 43% of IFPMA’s global expert pool.

Click to view PhIRDA IFPMA ICH Expert List.