The 2025 ICH Interim Meeting was successfully held from March 13 to 16 in Budapest, Hungary. During the meeting, four Expert Working Groups (EWGs) and two Implementation Working Groups (IWGs) convened to advance their respective agendas. The global implementation of ICH Guidelines will lay a solid foundation for further international regulatory harmonization in pharmaceutical R&D.

Three Working Group Lead Experts nominated by the China Pharmaceutical Innovation and Research Development Association (PhIRDA) were invited to attend the meeting in person. Representing the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the experts participated in the revision and discussion of ICH M14, Q2(R2)/Q14, and S13 Guidelines. The experts are as follows:

Three working groups achieved significant progress during the meeting. The M14 EWG revised and reviewed the draft guideline based on collected feedback, and finalization is expected in 2025. The Q2(R2)/Q14 IWG reached consensus on the content of each training module and revised the module outline, with the final version of the training materials expected by May 2025. The S13 EWG conducted in-depth discussions on the key contents of the technical document and draft guideline in its first phase, achieving broad agreement. The group will now proceed to the guideline drafting stage.

The three WG Lead Experts have demonstrated professionalism and responsibility, playing a critical role in the coordination of technical standards, industry-regulatory dialogue, and international rule-making. In addition to regularly organizing working group meetings, they actively participated in person at ICH international meetings, serving as a bridge between global industry stakeholders and regulatory authorities. Their efforts have deepened international exchanges among experts, facilitated the alignment of Chinese regulatory practices with international standards, and enhanced the integration of China’s pharmaceutical innovation ecosystem into global frameworks. Their contributions have significantly elevated China’s involvement and influence in global pharmaceutical regulatory development, offering Chinese insights to support global pharmaceutical innovation.

M14 EWG meeting (WANG Cunlin, third from left)

Q2(R2)/Q14 IWG representatives (XU Jufang, fifth from the left, front row)

S13 EWG representatives (GONG Xuelian, third from the left, second row)

As of March 2025, PhIRDA has nominated 59 experts (including 11 Lead Experts and 9 Alternates) to 29 IFPMA ICH Working Groups, accounting for 37% of IFPMA’s global experts. The next ICH Assembly will be held from May 13 to 14, 2025, in Madrid, Spain. PhIRDA will continue to actively coordinate the participation of working group experts, ensure deep engagement in international rule-making, and speak on behalf of China’s pharmaceutical industry to enhance global regulatory mutual recognition and foster the development of the global pharmaceutical sector.