30日通道正式落地，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, aiming to expedite the approval process for eligible applications [1][2][3]. Group 1: Policy Changes - The 30-day review channel is designed for innovative drug clinical trial applications, including traditional Chinese medicine, chemical drugs, and biological products, which meet specific criteria [3][4]. - The new policy emphasizes that the leading researchers for Phase III international multi-center clinical trials should primarily be from Chinese clinical trial institutions [4][5]. - The NMPA has been continuously optimizing the clinical trial management system to promote drug innovation and development, reducing the average review time from about 50 working days to 30 [1][7]. Group 2: Impact on Drug Development - The introduction of the 30-day channel is expected to further accelerate the clinical trial process for innovative drugs, which is crucial as this phase is often the longest in new drug development [2][3]. - The approval of 43 innovative drugs in the first half of this year represents a 59% year-on-year increase, indicating a significant boost in the domestic drug development landscape [7]. - The NMPA's reforms have led to a notable increase in the efficiency of drug review processes, with some regions achieving review times as short as 18 working days [7][8]. Group 3: Industry Collaboration and Risk Management - The 30-day channel requires applicants to commit to starting clinical trials within 12 weeks of approval, which emphasizes the need for efficient collaboration among all parties involved [5][9]. - The NMPA stresses the importance of maintaining high safety standards while expediting the review process, ensuring that clinical trials adhere to existing international standards [9]. - A new guideline for risk management during the drug development process has been introduced to help manage potential risks throughout the clinical trial lifecycle [9].