From May 10 to 14, 2025, the ICH Assembly was held in Madrid, Spain. During the ICH MC meeting, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) was appointed as a Standing Observer to MedDRA Steering Committee (SC) of the Medical Dictionary for Regulatory Activities (MedDRA). Entrusted by IFPMA, the China Pharmaceutical Innovation and Research Development Association (PhIRDA) successfully nominated three experts to join the IFPMA ICH MedDRA Expert Working Group. Among them, Ms. GUO Xiaojun, Vice President of Drug Safety and Pharmacovigilance at HUTCHMED, has been appointed as the Lead of the Task Force. She will participate in the work of the MedDRA SC and provide input directly to the ICH Management Committee.
MedDRA, through its standardized terminology and dynamic update mechanism, provides a scientific foundation for the global regulation of medical products. The inclusion of these three experts is expected to contribute significantly to the operational management of medical terminology, the establishment of globally harmonized standards, and the coordination of international regulatory practices.
The three experts joining the IFPMA ICH MedDRA Expert Working Group are listed below:
No. | Role | Name | Title & Position |
1 | Lead | GUO Xiaojun | Vice President of Drug Safety and Pharmacovigilance, HUTCHMED |
2 | expert | MENG Yuan | Chief Medical Officer and R&D Head, TJ Bio |
3 | expert | GAO Yu | Director, Medical Safety Review Physician, BeiGene |
As of May 2025, PhIRDA has nominated 63 experts (including 12 Leads and 9 Alternates) to 30 IFPMA ICH Expert Working Groups, accounting for 37% of IFPMA’s global expert pool.
Click to view PhIRDA IFPMA ICH Expert List