Beijing Borui Medical Technology Co., Ltd., as a representative of the industry, participated in the kickoff meeting of the research project "Research on Details of Clinical Technical Requirements for Drugs Marketed Overseas But Not Marketed in China" organized by the China Society for Drug Regulation (CSDR). The attendees included Zhang Wei, President of CSDR, Xie Songmei, Director of the Department of Clinical Medicine of the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), Professor Shao Rong, research leader and Deputy Director at China Pharmaceutical University, and her research team. Representatives from RDPAC, as well as industry representatives from companies such as Yangtze River Pharmaceutical Group, Tide Pharmaceutical, and Cisen, were also present. Through the discussions during the meeting, an analysis was conducted on the issue of global drug entry into the Chinese market. The meeting also discussed the handling principles for specific scenarios based on existing guidelines. It was emphasized that this research is an important approach to addressing drug lag, enabling timely access to quality global medications for Chinese patients, providing clear research and development decisions for the Chinese pharmaceutical industry, promoting participation in global competition, and ensuring effective allocation of resources to projects with the highest value by regulatory agencies. The meeting achieved a high consensus among regulatory agencies, research institutions, and the pharmaceutical industry regarding the value and significance of this research. Subsequently, there will be active efforts to further promote the research work of the project, laying a solid research foundation for the subsequent development of relevant policies by the CDE.

Clinical Requirement Guideline Research Initiative
