National Medical Products Administration: Eligible cell and gene therapy drugs will be included in the 30-day fast track review process for innovative drug clinical trials.

The National Medical Products Administration's comprehensive department is soliciting opinions on the "Announcement on Optimizing the Evaluation and Approval of Cell and Gene Therapy Drugs." It mentions encouraging research and development innovation to improve the quality and effectiveness of clinical research and development. The announcement also supports the research and development innovation of cell and gene therapy drugs guided by clinical value, focusing on key areas such as malignant tumors, rare diseases, genetic diseases, immune system diseases, and neurodegenerative diseases. It encourages conducting global synchronized research and international multicenter clinical trials in China, and includes eligible cell and gene therapy drugs in the innovative drug clinical trial evaluation and approval fast track process of 30 days to improve the quality and effectiveness of clinical research and development.