Experts recommended by China Pharmaceutical Association to participate in ICH expert working group

Source: China pharmaceutical innovation promotion association 2017-10-09 in December 2016, China Pharmaceutical Innovation Promotion Association (hereinafter referred to as "China pharmaceutical promotion association") formally joined the International Federation of Pharmaceutical Manufacturers & Associations (hereinafter referred to as "IFPMA") and became the only member of the association representing Chinese local pharmaceutical enterprises As a permanent observer of the International Coordinating Council for technical requirements of human drugs (ICH) and the ICH Secretariat, IFPMA was discussed and adopted at the ICH conference in June 2017 As an association representing the global biomedical industry, IFPMA is qualified to recommend experts to participate in the ICH guiding principles expert working group Recently, IFPMA has recruited experts for ICH M9, M10, E8 (R1), E19 and pediatric extraction, five ICH guidelines in the first stage Through internal screening, China pharmaceutical promotion association nominated 9 experts to participate in five working groups to IFPMA, and has received the reply from IFPMA All 9 experts nominated by China pharmaceutical promotion association have passed the review and become members of IFPMA ICH expert working group At the same time, Zhang Dan, the first chairman of the pharmaceutical research and Development Professional Committee of the China Council for the promotion of drugs and executive chairman of Fang en (Tianjin) Pharmaceutical Development Co., Ltd., was selected as the leader of the expert working group of "E19 optimization of safety data collection" and will represent IFPMA The ich-e19 expert working group attended the annual ICH conference and participated in the discussion of the ICH Conference; Cui Yimin, vice chairman of the pharmaceutical clinical research professional committee of the China Association for the promotion of drugs and director of the clinical trial center of Peking University First Hospital, was selected as "the biological exemption of m9-bcs (ICH M9- Wang Xiaoling, director of Pharmacy Department of Beijing Children's Hospital, was selected as the alternate leader of pediatric extrapolation working group Other selected experts include: ICH E8 - review of general considerations for clinical trials: Wang Yinxiang, chairman and chief medical officer of Beijing jiakesi new drug research and Development Co., Ltd and Xu Ning, executive vice president of zaiding Pharmaceutical (Shanghai) Co., Ltd., chairman of the pharmaceutical research and Development Professional Committee of China Council for the promotion of drugs; E19 - Optimization of safety data collection: Tan Feilai, member of Clinical Research Committee of Chinese Association for the promotion of drugs, senior vice president and chief medical officer of Beida Pharmaceutical Co., Ltd.; E10 - ICH M10 - biological method validation: Que Hong, vice president of quality control of Xinda biopharmaceutical (Suzhou) Co., Ltd., Zhou Qinwei, chief operating officer of Xinda biopharmaceutical (Suzhou) Co., Ltd., and Chen MINLING, director of Pharmacy Department of Shanghai Children's medical center The second meeting of ICH in 2017 will be held in Geneva, Switzerland, from November 11 to 16 At that time, experts of all working groups will meet face to face, and experts of relevant working groups will attend the ICH meeting and participate in the discussion on behalf of CCPD China's State Food and Drug Administration (CFDA) officially became a member of ICH in 2017 and is currently actively participating in the revision of ICH guidelines The participation of experts from the Chinese pharmaceutical industry will give a Chinese voice in the field of international new drug research and development, and offer suggestions and suggestions for improving the level of new drug research and development in China At the same time, after joining the ICH, CFDA will participate in the revision of ICH guidelines Currently, the ICH work office has been formally established, which is located in the drug review center (CDE) of the State Food and drug administration, and CDE will set up a series of working groups on relevant guidelines Entrusted by CDE, CFDA has sent experts to the CDE working group to participate in the discussion of relevant guidelines, contribute our wisdom to the revision of ICH guidelines, and provide decision-making reference and intellectual support for the development of the pharmaceutical industry As an association representing local pharmaceutical enterprises, China Council for the promotion of drugs is looking forward to participating in the pharmaceutical policy reform more widely and deeply through more ways, showing the progress and development of Chinese pharmaceutical innovation to the global industry, and playing a greater role in the pharmaceutical policy reform.