In a meeting chaired by Party Secretary and Director of the National Medical Products Administration (NMPA) Li Li on July 30, 2024, the “Pilot Work Plan for Optimizing Clinical Trial Review and Approval of Innovative Drugs” was given the green light. The initiative aims to enhance the quality and efficiency of drug clinical trials, with an ambitious target of reviewing and approving innovative drug clinical trial applications within 30 working days, thereby reducing the start-up time for such trials in the pilot regions.
The pilot program will be implemented in areas that have demonstrated advanced clinical trial management and supportive policies, along with robust industrial capabilities in the clinical research and development of innovative drugs. The plan removes geographical restrictions for applicants seeking to participate in the pilot project, allowing for a more flexible and nationwide approach to clinical trial applications.
The forthcoming “Pilot Work Plan for Optimizing Clinical Trial Review and Approval of Innovative Drugs” is set to be published shortly. The NMPA is committed to upholding principles of fairness, impartiality, and transparency in the review process, ensuring that all applications are rigorously assessed according to current technical standards. The administration has pledged to strengthen its collaboration with applicants, clinical trial institutions, and provincial drug regulatory authorities to facilitate the successful implementation of the pilot work.- Flcube.com
