From November 2 to 6, 2024, the ICH Assembly was held in Montreal, Canada, and several ICH Guidelines entered different revision stages. Entrusted by IFPMA, PhIRDA successsfully nominated five experts to participate in relevant IFPMA ICH Expert Working Groups (EWGs). These experts deeply involved in the development, revision, and implementation of ICH Guidelines, making significant contributions to the harmonization of international regulations. Below is the list of EWGs and experts:
No. | IFPMA ICH EWG | Name | Company/Institution and Position |
1 | M15: General Principles for Model-Informed Drug Development | ZHENG Shansong | Director Clinical Pharmacology,Qilu Pharmaceutical Co., Ltd. |
2 | Q1/Q5C: Targeted Revisions of the ICH Stability Guideline Series | ZHANG Xingyi | Vice President, Head of Regulatory Science, Simcere Pharmaceutical Group limited |
3 | SHEN Zhenduo | Director of Analysis, Shandong Boan Biotechnology Co., Ltd. | |
4 | Cell and Gene Therapies Discussion Group | CAO Xiaoping | Vice President, China Technical Operations, Legend Biotech |
5 | KONG Yan | Site Quality Head, FosunKite |
As of January 2025, PhIRDA has nominated 60 experts (including 11 Leads and 9 Alternates) to 29 IFPMA ICH EWGs, accounting for 37% of the total global IFPMA experts. The experts nominated by PhIRDA have been actively engaged in international regulatory rule-making, demonstrating the professional expertise and innovation capabilities of China’s pharmaceutical industry.
In the coming year, PhIRDA will remain committed to its mission of “Innovation, Industrialization, and Internationalization”, further deepening cooperation with IFPMA, and representing the Chinese pharmaceutical industry in the development and revision of international regulations. PhIRDA will continue to contribute to the high-quality development of global pharmaceutical innovation.
2025 ICH Assembly and Meetings Schedule
Event | Time | Location |
ICH Interim Meeting | March 13-16, 2025 | Budapest, Hungary |
ICH Assembly | May 10-14, 2025 | Madrid, Spain |
ICH Assembly | November 2-6, 2025 | Singapore |
Click to see PhIRDA IFPMA ICH Expert List