打造医药创新高地 国家级药械审评中心落地北京

Core Viewpoint - The establishment of the Beijing-Tianjin-Hebei (Jing-Jin-Ji) Center for Drug and Medical Device Review and Inspection aims to enhance the quality and efficiency of drug and medical device regulation, promoting high-quality development in the pharmaceutical industry across the region [1][2]. Group 1: Overview of the Jing-Jin-Ji Center - The Jing-Jin-Ji Center was inaugurated on September 21 and will serve Beijing, Tianjin, Hebei, and Shandong, leveraging three major centers and four service stations to create a comprehensive service network for the biopharmaceutical industry [1][2]. - The center will provide technical services including research and development guidance, consultation, and review communication, focusing on accelerating the review and approval processes for urgently needed innovative drugs and medical devices [2][3]. Group 2: Services and Support for Enterprises - The Jing-Jin-Ji Center will establish flexible communication channels with enterprises to address uncertainties in drug development, offering in-depth discussions on key technical issues to streamline processes and enhance efficiency [3][4]. - The center will implement an annual training plan based on regional industry needs, providing targeted courses to meet diverse training demands [3][4]. Group 3: Integration and Standardization - The center's operations will be integrated into the unified work system of the National Medical Products Administration (NMPA), promoting standardized drug inspection and resource mutual recognition across the four regions [3][7]. - The establishment of the center is expected to enhance the quality of application materials and optimize the allocation of review resources, with over 1,200 enterprises served and more than 3,000 consultation issues resolved by 2025 [6][7]. Group 4: Strategic Collaboration and Future Goals - The Beijing government will strengthen strategic cooperation with the NMPA to create an efficient regional drug and medical device review system, positioning the Jing-Jin-Ji Center as a platform for high-quality integrated development and innovation in the pharmaceutical industry [7][8]. - The center aims to facilitate the integration of research, production, and clinical resources across the Jing-Jin-Ji and Shandong regions, aligning product development with clinical needs and regional health demands [7].