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].

此次征求意见稿，拟统一符合资质要求的药物范畴，并在"生物制品1类创新药"的基础上，还明确纳入 符合要求的"中药""化学药品"。 在北京、上海等地试点约一年后，国家药监局再度发文，拟明确"纳入创新药临床试验审评审批30日通 道"的药物范畴。 16日，国家药监局发布《关于优化创新药临床试验审评审批有关事项的公告（征求意见稿）》（以下简 称"征求意见稿"），其中提到，为进一步支持以临床价值为导向的创新药研发，提高临床研发质效，对 符合要求的创新药临床试验申请在30个工作日内完成审评审批。 药物临床试验是创新药研发的关键环节，开展优化创新药临床试验审评审批试点工作，是提升临床试验 质量和效率和促进医药新质生产力发展的重要举措。近一年以来，"药品临床试验审批时限从60日压缩 至30日"已在全国部分地区试点推开，并获得国家药监局的支持。 根据征求意见稿，药物临床试验申请审评审批30日通道支持国家重点研发品种，鼓励全球早期同步研发 和国际多中心临床试验，服务临床急需和国家医药产业发展。 比如，根据上海市于去年7月30日发布的"关于支持生物医药产业全链条创新发展的若干意见"，推动实 施国家改革试点，将药品补充申请审评时限压缩 ...