On July 31, 2024, China's NMPA launched a pilot program aimed at improving the review and approval process for innovative drug clinical trials. The initiative seeks to establish a system and mechanisms that significantly enhance the quality and efficiency of these trials, specifically targeting the completion of review and approval for innovative drug clinical trial applications within 30 working days.
The pilot program focuses on clinical trial applications for Class 1 innovative drugs (excluding cell and gene therapy products, vaccines, etc.). Applicants are not restricted by location but must have at least three approved clinical trial applications for innovative drugs, extensive experience in conducting clinical trials and managing drug safety, and the ability to carry out a thorough risk assessment and develop a robust risk management plan before submitting application for Class 1 innovative drugs.
Beijing and Shanghai were designated as pilot cities on August 2, 2024. By the end of August 2024, the NMPA will announce more pilot cities and start the application process. The pilot program is set to run for one year, with a mid-term evaluation scheduled for January 2025 and a final review of the pilot experience to be completed by July 2025.
