创新药临床试验审评审批试点

Search documents
北京“两区”建设五周年:17款创新药、54款三类器械获批,数量位居全国前列
Bei Jing Shang Bao· 2025-06-19 11:49
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].