创新药临床试验审评审批再提速

Core Viewpoint - The National Medical Products Administration (NMPA) has officially launched a 30-day review and approval channel for innovative drug clinical trials, aimed at accelerating the drug development process in China [1][3]. Group 1: Overview of the 30-Day Channel - The 30-day channel for clinical trial applications is designed for innovative drugs that meet specific criteria, including traditional Chinese medicine, chemical drugs, and biological products [3][4]. - The introduction of the 30-day channel follows the implementation of a 60-day implied approval system in 2019, which significantly improved the efficiency of clinical trial reviews [3][8]. - The NMPA aims to enhance the speed of clinical trials while maintaining high safety standards, ensuring that the review process does not compromise the quality of drug safety assessments [9][10]. Group 2: Conditions for Eligibility - To qualify for the 30-day channel, drug applications must demonstrate significant clinical value and can include pediatric drugs, rare disease drugs, and traditional Chinese medicine [4][5]. - The channel encourages global synchronized research, requiring that Phase III international multi-center clinical trials be primarily led by Chinese clinical trial institutions [4][5]. - Applicants must commit to initiating clinical trials within 12 weeks of approval, which emphasizes the need for efficient clinical operations [6][8]. Group 3: Impact on the Industry - China's innovative drug development is rapidly advancing, with over 20% of the global pipeline of new drugs currently under research [8]. - In the first half of 2025, the total amount of innovative drug licensing reached nearly $66 billion, reflecting growing international recognition of Chinese innovative drugs [8]. - The NMPA's ongoing reforms in the review and approval system have led to a significant increase in the number of approved innovative drugs, with 43 approvals in the first half of the year, marking a 59% year-on-year increase [8][9].