China Implementing Pilot Work Program for Expedited Clinical Trial Review and Approval

China's National Medical Products Administration ("NMPA") recently issued the Notice on the Issuance of the Pilot Work Program for Optimizing the Review and Approval of Innovative Drug Clinical Trials ("Pilot Work Program"). This initiative aims to enhance the efficiency of the drug clinical trial review and approval processes. Under the Pilot Work Program, innovative drug clinical trial applications will be reviewed and approved within 30 business days, which is a significant reduction from the usual 60 business days.

Key features of the Pilot Work Program are as follows:

• Application Scope: The current scope is limited to Class I innovative drugs (new to the world innovative drugs). Clinical trials for cell and gene therapy products and vaccine products are currently excluded from the Pilot Work Program.

• Implementing Regions: The Pilot Work Program will be implemented only in regions with comprehensive clinical trial support policies and strong capacity for innovative clinical research and development. Thus far, only the Beijing and Shanghai MPAs have been approved by the NMPA to carry out the Pilot Work Program.

• Clinical Trial Applicants: Applicants under this Program must have had at least three innovative clinical trials approved in China or abroad. Under China's drug registration classification, innovative drugs generally refer to new to the world drugs. This ensures that applicants have enough experience in clinical trial implementation and research and development pharmacovigilance management.

• Clinical institutions: Institutions (i.e., hospitals) conducting the clinical trials must be registered with the drug clinical trial institution record-filing platform and have completed at least three innovative drug clinical trials as the leading site. The ethics committees of these sites must be capable of conducting preliminary and follow-up reviews of the clinical trial program's risk management plans. The principal investigator must have presided over at least three innovative drug clinical trials as the principal investigator of the leading site. The Beijing and Shanghai MPAs have approved 17 (here and here) and 14 (here) clinical institutions, respectively, to participate in the Pilot Work Program.

• Application Process: To file an application, the applicant must submit the following materials to a provincial-level MPA: (1) a Pilot Work Program application form; (2) the contract review opinion or receipt issued by the clinical trial institution; (3) the clinical trial protocol signed by the principal investigator; (4) the review opinion or receipt issued by the ethics committee; and (5) the risk management plan jointly confirmed by the applicant, principal investigator, and ethics committee. The authorized provincial-level MPAs will consult the Center for Drug Evaluation ("CDE") and confirm with the applicant within five business days whether they can participate in the Pilot Work Program. Once confirmed, the CDE will review the applications and make a decision on approval within 30 business days.

The clinical trials under the Pilot Work Program should commence within 12 weeks after obtaining approval. The implementation period of the Pilot Work Program will last for one year. The NMPA will conduct a mid-term assessment in January 2025 and summarize project experiences in July 2025 to determine whether the program can be replicated and promoted more broadly.

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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Kaixin Fan, and Kexin Yang.

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