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一款创新药如何少走弯路?每经记者走访药监局、药检院 还和药企、三甲医院聊了这些……
Mei Ri Jing Ji Xin Wen· 2025-10-21 14:24
Core Viewpoint - The article discusses the recent advancements in the approval process for innovative drugs in Beijing, highlighting the efforts made to optimize clinical trial reviews and approvals, thereby accelerating the availability of new medications to patients. Group 1: Clinical Trial Approval Process - The approval time for clinical trials in Beijing has been reduced from 60 working days to 30 working days, with some projects receiving approval in as little as 18 working days [1][4][5] - In the first half of this year, the overall pre-approval rate for clinical trials was 34.8%, with a parallel review rate of 23.5% for ethical and project approvals [1] - The average review time for clinical trial applications during the pilot program was 24.6 working days, with the fastest approval taking only 18 working days [5] Group 2: Innovative Drug Fast-Track Approval - A "dual-channel" mechanism has been implemented for drug approvals, allowing certain innovative drugs to enter a 30-day fast-track approval process based on clinical need [6] - The focus is on drugs for rare diseases, pediatric use, and those requiring global synchronized development [6] - The approval speed for innovative drugs has improved significantly, with some applications being processed in as little as 21 days [5] Group 3: Import Drug Inspection and Approval - Since the beginning of 2024, Beijing has attracted 67 new imported drug varieties, with a total value of $7.9 billion, and has implemented measures to expedite the inspection process [11] - The inspection time for certain targeted drugs has been reduced to as little as 7 to 19 days, significantly speeding up the time from approval to patient access [12] - The introduction of segmented production for imported drugs allows for more flexible resource allocation and faster market entry [13]