The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a key role in standardizing and harmonizing global drug development and regulatory processes. As a member of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), China Pharmaceutical Innovation and Research Development Association (PhIRDA) has actively nominated Chinese experts to participate in IFPMA ICH Expert Working Groups (EWGs), contributing to the harmonization of international guidelines. As a bridge between the Chinese pharmaceutical industry and regulatory authorities, PhIRDA has also been committed to promoting the implementation of ICH guidelines in China. 

On this occasion, PhIRDA would like to take this opportunity to extend the highest respect to all IFPMA ICH EWG experts and CDE ICH Working Group (WG) experts for their time, effort, and dedication to the development and revision of ICH Guidelines at both international and domestic levels. PhIRDA also sincerely appreciates the strong support provided by their organizations. 

Ø IFPMA ICH-Related Activities

In 2024, PhIRDA actively nominated industry experts to IFPMA, successfully nominating 18 experts to join eight IFPMA ICH WGs (M7 sub-group, M11, M13, M15, Q1/Q5C, Q3E, S13, CGTDG) as well as the IFPMA-WHO Clinical Forum Ad Hoc Working Group.

February 2024: WU Yun (Tide Pharmaceutical) and ZHANG Qiuyang (BeiGene) joined the IFPMA ICH M13 EWG.

March 2024: WANG Yi (Jacobio Pharma) and WANG Xingli (Fosun Pharma) joined the IFPMA-WHO Clinical Forum Ad Hoc Working Group.

March 2024: SUN Xiaodong (Dualitybio) and WANG Haiyan (Qilu Pharmaceutical) joined the IFPMA M11 EWG.

April 2024: DUO Jia (Innovent Biologics) and LIU Jing (BeiGene) joined the IFPMA ICH Q3E EWG.

June 2024 (ICH Assembly, Fukuoka, Japan): LI Wenbin (Beijing Tiantan Hospital), AN Zhenming (Qilu Pharmaceutical), and XU Jufang (CF PharmTech) attended the meeting.

June 2024: GONG Xuelian (Shanghai Pharmaceutical), YANG Yongsheng (Createrna Science and Technology), and HUANG Ze’ao (Youcare Pharmaceutical) joined the IFPMA ICH S13 EWG.

August 2024: Jane WANG (Salubris Pharmaceuticals) and MAO Yadan (Hengrui Pharmaceutical) joined the IFPMA ICH M7 Sub-group EWG.

November 2024 (ICH Assembly, Montréal, Canada): LI Wenbin (Beijing Tiantan Hospital), AN Zhenming (Qilu Pharmaceutical), and MENG Yuan (I-Mab Biopharma) attended the meeting.

December 2024: ZHENG Shansong (Qilu Pharmaceutical) joined the IFPMA ICH M15 EWG, while ZHANG Xingyi (Simcere Pharmaceutical) and SHEN Zhenduo (Shandong Boan Biotechnology) joined the IFPMA ICH Q1/Q5C EWG. CAO Xiaoping (Legend Biotech) and KONG Yan (FosunKite) joined the ICH CGTDG.

Over the past year, IFPMA ICH experts nominated by PhIRDA have actively participated in the development and revision of various ICH Guidelines, deeply engaging in international regulatory harmonization efforts and demonstrating outstanding professionalism. Four WG leads nominated by PhIRDA attended the ICH Assembly meetings in Japan and Canada in person, with LI Wenbin and AN Zhenming participating in twice. These contributions have laid a solid foundation for further advancing global regulatory harmonization in drug development and regulation.

Ø Implementation of ICH Guidelines in China

In 2024, the National Medical Products Administration (NMPA) was re-elected as a member of ICH Management Committee for the third time. This milestone demonstrates China’s new drug development and registration technical standards are now fully aligned with international regulations. The country’s drug regulatory internationalization efforts have gained global recognition, and China’s influence in international regulatory organizations has significantly increased. PhIRDA has played an active role in promoting the implementation of ICH Guidelines in China, receiving broad recognition and high praise from regulatory agencies and the pharmaceutical industry.

In 2024, PhIRDA recommended 23 experts to join four CDE ICH WGs. Notably, AN Zhenming and DING Faming were appointed as the Lead of the IFPMA ICH Q6(R1) WG and expert in the IFPMA ICH E22 WG respectively. Having previously participated in the international revision of related guidelines, they bring extensive industry experience and a global perspective, contributing significantly to the smooth implementation of these guidelines in China.

In 2024, NMPA adopted and implemented five ICH Guidelines. PhIRDA extensively collected industry feedback on these guidelines, laying a solid foundation for their smooth regulatory implementation in China.

We are pleased to see that ICH Guidelines are now fully implemented in China. This alignment brings China’s regulatory requirements closer to those of the U.S., EU, and Japan, facilitating simultaneous drug development and registration both domestically and internationally. It also accelerates the market access of clinically urgent imported drugs in China, allowing Chinese patients to benefit from the latest global innovations more rapidly. 

Looking ahead, PhIRDA will continue to actively participate in ICH activities, further coordinating the involvement of Chinese experts in international rule-making and implementation, fostering China’s integration into the global innovation system, and contributing to the collaborative development of the global pharmaceutical industry.

Click to see PhIRDA IFPMA ICH Expert List