助力首都打造医药创新高地，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][3]. 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 a comprehensive service network to support the biopharmaceutical industry [1][3]. - The center will provide technical services including research guidance, consultation, and review communication, focusing on accelerating the review and approval processes for urgently needed innovative drugs and medical devices [3][4]. Group 2: Service Network and Collaboration - The center will create a "3+1+4+N" service network, integrating resources from the national drug review centers and local innovation service stations to enhance collaboration and efficiency [7]. - It will facilitate early involvement of review experts in key areas such as artificial intelligence, providing tailored guidance to improve the quality of application materials [7][8]. Group 3: Training and Support for Enterprises - The Jing-Jin-Ji Center will establish flexible communication channels with enterprises, offering in-depth discussions on critical technical issues to streamline the development process [4][6]. - An annual training plan will be developed based on industry needs, addressing diverse training requirements to support the pharmaceutical sector [4][8]. Group 4: Regional Coordination and Standardization - The center's operations will be integrated into a unified system under the national drug regulatory framework, promoting standardized inspection processes and resource sharing among the four regions [8]. - The initiative aims to enhance the alignment of product development with clinical needs and regional health demands, fostering a deeper integration of the innovation and industrial chains [8].