From May 10 to 14, 2025, the ICH Assembly was successfully held in Madrid, Spain. During the meeting, the ICH continues to expand Dirección Nacional de Vigilancia Sanitaria (DINAVISA), Paraguay; Ministry of Health (MOH), Kuwait; and Superintendencia de Regulación Sanitaria (SRS), El Salvador as new ICH Observers, bringing ICH to a total of 23 Members and 41 Observers.

During the ICH Assembly, 11 ICH Expert Working Groups (EWGs) convened to advance the international harmonization of guidelines. Two experts from the China Pharmaceutical Innovation and Research Development Association (PhIRDA) were invited to attend in person: LI Wenbin, Lead of the ICH M11 EWG and Chair of Cancer Center at Beijing Tiantan Hospital, Capital Medical University; and GUO Tong, Alternate of the ICH M14 EWG and Senior Advisor at GoBoard Healthcare Group. They participated on behalf of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in discussions on the revision of relevant ICH guidelines.

Both working groups made significant progress during the meeting. The M11 EWG reviewed and addressed approximately 150 comments received during public consultation and discussed training materials related to the M11 guideline. The M14 EWG examined all submitted comments item by item, discussed the proposed revisions, and finalized the document. The next step will be to advance the adoption and official release of the M14 guideline.

Additionally, the Assembly resolved to admit the National Medical Products Administration of China (NMPA) and the Saudi Food and Drug Authority (SFDA) as Regulatory Members of the MedDRA Steering Committee (SC), and to designate IFPMA as a Standing Observer of the Committee. As a member of IFPMA, PhIRDA successfully recommended Ms. GUO Xiaojun, Vice President of Drug Safety and Pharmacovigilance at HUTCHMED, to serve as the Lead of the IFPMA ICH MedDRA Expert Working Group, directly participating in the work of the MedDRA SC.

In addition, 19 other IFPMA ICH experts recommended by PhIRDA actively contributed to the work of various EWGs during the Assembly, through internal discussions and consultations. These efforts helped build a bridge for dialogue between the global pharmaceutical industry and regulatory bodies, promoted the alignment of China’s industry standards with international norms, enhanced China’s participation and influence in the global rule-making process for pharmaceuticals, and contributed Chinese expertise to global pharmaceutical innovation.

M11 EWG (4th row, 1st from right: LI Wenbin)

Group photo (2nd row, 4th from right: LI Wenbin; 2nd row, 2nd from right: GUO Tong)

As of May 2025, PhIRDA has recommended 63 experts (including 12 Leads and 9 Alternates) to 30 IFPMA ICH EWGs, accounting for 37% of IFPMA’s global expert pool. The 2025 ICH Assembly will be held in Singapore on November 18-19. PhIRDA will continue to actively coordinate expert participation, engage deeply in the development and revision of international regulations, represent the voice of the Chinese pharmaceutical industry, and contribute to the high-quality development of the global pharmaceutical sector.

Learn more: PhIRDA IFPMA ICH Expert List