In December 2016, China Pharmaceutical Innovation and Research Development Association (PhIRDA) officially joined the International Federation of Pharmaceutical Manufactures & Associations (IFPMA) as the only member of the association representing local pharmaceutical enterprises in China. As the permanent observer and secretariat of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the association representing the global biopharmaceutical industry, IFPMA was qualified to recommend experts to participate in the Expert Working Groups (EWGs) on ICH guidelines held in ICH Conference in June 2017.

In June 2018, two new guidelines: E20 Adaptive Clinical Trials and M12 Drug Interaction Studies was announced to establish in the ICH Assembly meeting held in Kobe, Japan. The ICH Management Committee approved IFPMA to establish informal EWGs of E20 and M12 respectively, and entrusted PhIRDA to recommend experts. After selection, PhIRDA nominated 4 experts to IFPMA, and received an official reply from IFPMA that all recommended experts have been included as formal members of the informal EWGs. PhIRDA is qualified as the leader of IFPMA ICH M12 informal WG and alternate leader of E20 informal EWG.

List of informal EWGs:

Leader of M12 EWG: Tao Xiaolu, Vice President of Clinical Pharmacology, CStone Pharmaceutical Co. Ltd.

Expert of M12 EWG: Sun He, Vice President of Tasly Pharmaceutical Group Co., Ltd.

Alternate leader of E20 EWG: Lu Zhihong, R&D Vice President of Jiangsu Simcere Pharmaceutical Co., Ltd.

Expert of E20 EWG: Zhang Nan, Senior Director for Biostatistics of dMed Biopharmaceutical Co., Ltd.

In 2018, PhIRDA recommended another 6 experts participating in 3 IFPMA ICH informal EWGs, namely Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation, Q13 Continuous Manufacturing, M11 Clinical Electronic Structured Harmonized Protocol, CeSHarP. Authorized by ICH Management Committee, the 3 informal EWGs have been approved as formal EWGs.

List of EWG:

Alternate leader of Q13 EWG: Zhang Junli, Senior Vice President of Shanghai Henlius Biotech, Inc.

Expert of Q13 EWG: Ye Zhehong, Senior Vice President and CQO of JW Therapeutics

Alternate leader of Q2(R2)/Q14 EWG: Zhang Bo, Senior Vice President of Zai Lab Co., Ltd.

Expert of Q2(R2)/Q14 EWG: Jiang Caihua, Vice President of Quality Department and CQO of Shanghai Henlius Biotech, Inc.

Alternate leader of M11 EWG: Wang Xinghe, Director of New Drug Clinical Trial Center of Beijing Shijitan Hospital, CMU

Expert of M11 EWG: Li Wenbin, Professor of Beijing Tiantan Hospital, CMU

The domestic pharmaceutical experts recommended by PhIRDA have been approved into IFPMA ICH EWGs and appointed as leaders through selection, which not only engages China in the direct formulation of international rules, learning and drawing experience at an international level, but also express opinions on behalf of PhIRDA and pharmaceutical industry in China, so as to enhance the ability of Chinese innovative drugs R&D and clinical trial, and promote the transformation and implementation of ICH Guidelines in China.