创新药临床试验审评审批增设30日通道，支持三类新药

Core Viewpoint - The National Medical Products Administration (NMPA) has implemented a new policy to accelerate the clinical trial review and approval process for innovative drugs, introducing a 30-day fast track for certain applications, thereby enhancing the overall drug development ecosystem in China [1][2][3] Group 1: Policy Implementation - The NMPA's announcement on September 12 aims to optimize the clinical trial review and approval process for innovative drugs, establishing a 30-day fast track in addition to the existing 60-day implied approval period [1][2] - The new policy is part of a broader initiative to support the high-quality development of the pharmaceutical industry and aligns with the State Council's directives for comprehensive reform in drug and medical device regulation [2][3] Group 2: Eligibility Criteria - To qualify for the 30-day fast track, clinical trial applications must be for innovative drugs that are either supported by the national policy framework, classified as pediatric or rare disease drugs, or involve global synchronized research [2][3] - The announcement clarifies that Phase III clinical trials must be led or co-led by domestic researchers to ensure that the trials are relevant to Chinese clinical practices [3] Group 3: Safety and Quality Assurance - The NMPA emphasizes that while accelerating the review process, it is crucial to maintain high safety and quality standards, ensuring that participant protection remains a priority [4][5] - The agency has committed to conducting the 30-day review process in accordance with international clinical trial standards, reinforcing the need for collaboration among research entities, trial institutions, and ethical review boards [5][6] Group 4: Risk Management - A new technical guideline for risk management during the innovative drug development process has been drafted to ensure that risk management principles are integrated throughout the drug lifecycle [6]