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

Core Viewpoint - The National Medical Products Administration (NMPA) is seeking opinions on a draft announcement to optimize the review and approval process for innovative drug clinical trials, proposing a 30-day fast track for certain categories of innovative drugs [1] Group 1: Regulatory Changes - Applications for the 30-day fast track must be for Class 1 innovative drugs, which include traditional Chinese medicine, chemical drugs, and biological products [1] - The application must meet at least one of the following criteria: 1. Key innovative drugs supported by national policies with significant clinical value [1] 2. Drugs included in the NMPA's Children's Drug Star Program or Rare Disease Care Program [1] 3. Globally synchronized research products, including Phase I, II clinical trials, and international multi-center clinical trials led by Chinese principal investigators [1]