Core Viewpoint - Beijing is implementing a series of innovative policies and achievements in the pharmaceutical regulatory field to promote high-quality industrial development, including the establishment of innovation service stations and streamlined approval processes for medical devices and drugs [1][3][4]. Group 1: Innovation Service Stations - Beijing has established the first provincial-level drug and medical device innovation service station in the country, along with a national-level medical device innovation service station, to accelerate the transformation of research results and promote the application of key innovative products [3]. - The Changping service station has served 1,373 enterprises and answered 2,185 inquiries, achieving a problem resolution rate of 97%. The average review time for the first registration of Class II medical devices has been reduced from the statutory 120 working days to 47 working days, a speed increase of approximately 61% [3]. Group 2: Support for Innovative Drug Production - In April, Beijing released 32 reform and innovation measures to support the high-quality development of innovative pharmaceuticals, including a pilot program for cross-border segmented production of biological products [4]. - The first approved product under this program is Johnson & Johnson's Nicaralizumab injection, which is notable for being the first imported biological product approved for segmented production in China, targeting rare diseases in patients aged 12 and above [4]. Group 3: Accelerated Drug and Medical Device Inspection - Beijing has achieved immediate inspection of urgently needed clinical drugs and medical devices, completing inspections for 9 varieties and 19 batches this year, with a total value of nearly $100 million [5]. - The Beijing Vaccine Inspection Center, set to be operational in November, will meet the annual inspection demand for 4,000 batches of vaccines, providing comprehensive technical support from research to production [5]. Group 4: Regulatory Reforms for Retail Pharmacies - New regulations for retail pharmacies in Beijing have been introduced, removing restrictions on the shareholding ratio of chain headquarters and allowing for the establishment of remote prescription centers to enhance pharmaceutical service capabilities [6]. - The regulatory body is also supporting the integration of resources among pharmaceutical wholesale enterprises to create a multi-warehouse collaborative logistics management model, significantly reducing operational costs for businesses [6]. Group 5: Future Directions - The Beijing Drug Administration plans to continue enhancing industrial innovation services, actively seeking pilot policies, and improving review and inspection efficiency to empower the high-quality development of the pharmaceutical and health industry in Beijing [6].
北京首设药械创新服务站,昌平服务站点已服务企业1373家次
Bei Jing Shang Bao·2025-06-26 14:01