拟压缩至30个工作日 创新药临床试验审批再提速

Core Viewpoint - The National Medical Products Administration (NMPA) of China is optimizing the clinical trial review and approval process for innovative drugs, establishing a 30-day review pathway to enhance the efficiency and quality of clinical research [1][2]. Group 1: Policy Changes - The NMPA has drafted a public consultation document to clarify the scope of drugs eligible for the 30-day clinical trial review pathway, which includes traditional Chinese medicine, chemical drugs, and biological products classified as Category 1 innovative drugs [1]. - The 30-day review pathway aims to support key national research varieties, encourage global early-stage simultaneous development, and facilitate international multi-center clinical trials [1][2]. Group 2: Application Requirements - Applicants for the 30-day review pathway must demonstrate thorough ethical review and compliance capabilities of the clinical trial institution and have established cooperation with the institution prior to submitting the application [2]. - The NMPA will set specific documentation requirements for the 30-day review pathway, and if technical reasons prevent completion within 30 days, a 60-day implied approval timeline will be followed [2]. Group 3: Pilot Program Results - Beijing has been approved as a pilot region for optimizing the clinical trial review process, with the approval timeline reduced from 60 days to 30 days, and the scope of trials expanded to include medical devices [3]. - As of now, 10 trial projects have been included in the pilot program in Beijing, with an average review time of 23.8 days, the shortest being 18 days, achieving a speed increase of up to 70% [3].