The ICH Assembly Meeting officially approved the Concept Paper of ICH M16: Structured Product Quality Submissions (SPQS), and a new expert working group on this topic was established. 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 M16 Task Force. Among them, Dr. LU Chenshu from BeOne Medicine has been appointed as the Alternate of the Task Force. He will be deeply engaged in the drafting and revision of the guideline, making significant contributions to the harmonization of international regulations.

The focus of this guideline is to adopt or develop global standards for data content and structure in submitting product quality information in a dossier to facilitate regulatory assessment and efficient communication between the applicants and regulators. The three experts joining the IFPMA ICH M16 Task Force are listed below:

As of November 2025, PhIRDA has nominated 70 experts (including 13 Leads and 10 Alternates) to 32 IFPMA ICH Task Forces, accounting for 43% of IFPMA’s global expert pool.

Click to view PhIRDA IFPMA ICH Expert List.