On September 7, 2023, the first International Biopharmaceutical Industry Innovation Conference Beijing Forum (hereinafter referred to as the “1st IBIIC•BJF”) convened in the Beijing Economic-Technological Development Zone. The 1st IBIIC•BJF is jointly organized by the Central Committee of the Chinese Peasants and Workers Democratic Party (CPWDP) and the People's Government of Beijing Municipal, with co-hosting by the Beijing Committee of the Chinese Peasants and Workers Democratic Party, the Beijing Economic-Technological Development Area Administrative Commission, and the Beijing Municipal Medical Products Administration. The 1st IBIIC•BJF focused on “innovation” and “internationalization”, with in-depth discussions and collaborative efforts in various areas of the biopharmaceutical sector, including cutting-edge technologies, innovative achievements, and international regulations. The platform’s aim is to promote international exchanges and mutual learning in the field of biopharmaceuticals, creating a robust platform for open cooperation that leads to high-quality industry development.
On September 11, 2023, the Special Forum of ICH Guidelines for Clinical Trials (hereinafter referred to as the “ICH Forum”), a significant component of the 1st IBIIC•BJF, was successfully held in the Beijing Economic-Technological Development Zone. The ICH Forum was jointly organized by the Peking University Clinical Research Institute (PUCRI) and the Peking University-Asia-Pacific Economic Cooperation Health Science Academy (HeSAY), with supportfrom the China Center for Food and Drug International Exchange (CCFDIE), the R&D-based Pharmaceutical Association Committee (RDPAC), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The ICH Forum was co-chaired by Wu Yangfeng, the executive associate director of PUCRI, Sara Wang, vice president of Science and Regulatory at RDPAC, and Janet Vessotskie, deputy vice president of Science and Regulatory at PhRMA.
The ICH forum focused on topics related to ICH E17 and ICH E6 (R3), delving into research progress by international regulatory authorities, academia, and industry stakeholders. Its aim was to assist the participants in understanding the latest international regulatory standards, promoting the development of China’s pharmaceutical industry, and supporting the implementation of and adherence to ICH guidelines in China. At the ICH forum, Zheng Xiaoying, dean of HeSAY, delivered a welcome address, followed by a keynote speech by Wen Baoshu, head of the Office of Quality Management of the Center for Drug Evaluation (CDE) and the ICH Coordinator of the National Medical Products Administration (NMPA). Special presentations were also given by Wang Jun, head of the Statistics and Clinical Pharmacology department of CDE, Yang Lan from the Compliance Department of CDE, and experts from Peking University, as well as several senior industry experts organized by PhRMA and EFPIA. The ICH Forum received strong support from PhRMA and EFPIA, founding members of ICH. A total of over 600 participants including government representatives, international experts and scholars, multinational corporate executives, and industry representatives from organizations such as RDPAC, PhRMA, EFPIA attended the forum both in person and online.
It is worth noting that China's drug regulatory authority joined the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017 and was re-elected as a member of the ICH Management Committee in 2021, thereby fully committing to globally recognized technical requirements for drug development and registration. In their comprehensive efforts to advance ICH work, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) collaborated closely and communicated extensively with academics and industry in a range of activities on the implementation of ICH guidelines, including forming consensus, drafting of relevant guidelines and training. The successful convening of the ICH Forum underscores the resolute determination of China’s drug regulatory authority to promote the implementation of ICH guidelines in China.
