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].

国家药监局征求意见：纳入创新药临床试验审评审批30日通道的申请 应当为中药、化学药品、生物制 品1类创新药 智通财经6月16日电，国家药监局综合司公开征求《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）》意见，其中提出，纳入创新药临床试验审评审批30日通道的申请，应当为中药、化学 药品、生物制品1类创新药，能够按要求提交申报资料，并需满足以下条件之一：（一）国家支持的重 点创新药。获国家全链条支持创新药发展政策体系支持的具有明显临床价值的重点创新药品种。（二） 入选国家药品监督管理局药品审评中心儿童药星光计划、罕见病关爱计划的品种。（三）全球同步研发 品种。全球同步研发的Ⅰ期、Ⅱ期临床试验和III期国际多中心临床试验，以及中国主要研究者牵头开展 的国际多中心临床试验。 ...