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) of ICH.
To further perfect the quality risk management of drug lifecycle, to improve the quality and accessibility, ICH announced to establish a Q9 (R1) – Quality Risk Management (QRM) Informal Working Group, discuss and solve problems generated during the implementation process of the guideline. After internal selection, PhIRDA nominated 2 experts to IFPMA, and one is qualified as the leader of the Informal Working Group.
List of IFPMA ICH Q9 (R1) Informal WG:
Leader: Xuejian XU, Senior Vice President Global Quality Assurance, WuXi Biologics
Expert: Qing SHEN, Senior Director of Quality Management, Shanghai Junshi Biosciences
Till now, 36 experts from the industry recommended by PhIRDA have been approved into 18 IFPMA ICH Task Forces, among which 13 were appointed as leaders, 7 as alternate leaders. Experts recommended by PhIRDA accounts for more than 50% among the current 65 IFPMA ICH experts. The domestic pharmaceutical experts’ deep participation in the IFPMA ICH EWG/Informal WG engages China in the direct formulation of international rules, expresses opinions on behalf of PhIRDA and pharmaceutical industry in China, and will surely enhance discourse power of China among the international organizations, promote the transformation and implementation of ICH Guidelines in China.