北京创新药临床试验审批缩至30日

Group 1 - The core viewpoint of the articles is that regulatory reforms in Beijing are significantly enhancing the pharmaceutical and healthcare industry, aiming for a market value exceeding one trillion yuan through various supportive policies [1][2][3]. Group 2 - The approval time for clinical trials of innovative drugs has been reduced from 60 days to 30 days, with some projects being approved in as little as 18 working days [2][3]. - A total of 26 drug varieties have been approved, including 21 for rare diseases, benefiting approximately 4,900 patients [2]. - The Beijing model includes measures such as bonded stockpiling and multiple uses of a single customs clearance to expedite access to urgently needed drugs [2][3]. Group 3 - The overall time for initiating clinical trial projects is targeted to be reduced from 28 weeks to under 20 weeks by 2024, with some hospitals already achieving a reduction to around 7 weeks [3][4]. - A green channel has been established for innovative drugs, allowing for simultaneous reviews of project initiation, ethical review, and contract review, significantly shortening approval times [4]. Group 4 - The National Medical Insurance Bureau has implemented a dynamic adjustment mechanism for the medical insurance catalog, adding 835 new drugs over seven years, including 149 innovative drugs [5]. - Approximately 80% of innovative drugs are expected to be included in the medical insurance catalog within two years of their market launch [5][6]. - In the first seven months of 2025, 13.05 million patients purchased national negotiated drugs, totaling 3.95 billion yuan in expenses [5]. Group 5 - A dual-channel supply mechanism for national negotiated drugs has been established to ensure accessibility and address issues related to slow and difficult hospital entry [5][6]. - The Beijing Medical Insurance Fund will separately pay 4.5 billion yuan for national negotiated drugs in 2024, ensuring that these drugs are not subject to DRG payment limits [6][7]. Group 6 - The establishment of a drug and medical device review center in the Beijing-Tianjin-Hebei region aims to accelerate the approval process for innovative drugs and medical devices [8]. - The center will provide comprehensive technical services, including guidance and consultation for drug and device registration, focusing on clinical needs [8].