Group 1 - Beijing has approved 17 innovative drugs and 54 Class III innovative medical devices in the past five years, ranking among the top in the country [1] - A comprehensive implementation plan for the biopharmaceutical industry chain was developed, proposing 50 specific measures across five areas: market access, supply chain, clinical application, international cooperation, and key element assurance [1] - Beijing established a provincial-level innovation service station for drugs and medical devices, and introduced a "white list" system for importing research and development materials [1] Group 2 - In 2024, a green channel for the import approval of urgently needed clinical drugs and devices will be established, focusing on rare disease medications [2] - A total of 23 clinical urgently needed drug imports have been approved in the past year, benefiting over 2,000 patients [2] - Drug review and approval reforms have reduced the approval time for innovative drug clinical trials from 60 days to 30 days, with some projects approved in as little as 18 working days [2] Group 3 - Beijing has created an integrated sampling inspection model for imported drugs, achieving customs clearance and sampling within 24 hours [3] - Over the past five years, the Tianzhu port has completed 15,000 customs clearances and over 5,100 sampling batches, with annual increases in clearance numbers [3] - From January to May, 613 batches of imported drug inspections were accepted, with a year-on-year value increase of 58% [3]

Core Insights - The Beijing Municipal Drug Administration has implemented a comprehensive plan to enhance the biopharmaceutical industry, achieving significant results in market access and regulatory measures [1][3]. Group 1: Policy Implementation and Achievements - A biopharmaceutical task force was established, resulting in the creation of 50 specific development measures across five areas, including market access [1]. - Over the past five years, 17 innovative drugs and 54 Class III innovative medical devices have been approved, positioning Beijing among the top in the nation [3]. - A green channel for the import approval of urgently needed drugs and medical devices has been established, benefiting over 2,000 patients with 23 approved clinical urgent drug imports in the past year [3]. Group 2: Regulatory Efficiency Improvements - Clinical trial approval times have been reduced from 60 days to 30 days, with trial initiation times cut to under 12 weeks, expediting the approval process for 11 projects [4]. - The review time for supplementary drug applications has been shortened from 200 days to 60 days, facilitating faster technological upgrades for companies [4]. - The introduction of an integrated sampling inspection model for imported drugs has enabled 24-hour completion of customs clearance and sampling, with a significant increase in the volume of imports [4]. Group 3: Future Directions - The Beijing Municipal Drug Administration plans to continue enhancing innovation services and seek pilot policies to further promote the development of the biopharmaceutical industry [5].