To optimize innovative new drug clinical trial approval process, the National Medical Products Administration (NMPA) has issued a pilot program to accelerate the development of high-quality pharmaceutical products and deepen reforms in the drug approval system.
One of the key goals is to ensure that applications for clinical trials of innovative new drugs are reviewed and approved within 30 working days instead of the current 60 working days, significantly shortening the timeline for the initiation of clinical trials. This accelerated process is expected to foster a more dynamic and efficient environment for drug development in China.
Eligibility and Requirements
1. Clinical trial applicants
The scope of the pilot program is restricted to the clinical trial application of Class 1 innovative new drugs, excluding certain categories such as cell and gene therapies, as well as vaccines. Both domestic and international applicants can apply to participate in this program provided they meet the following three requirements:
- They must demonstrate significant experience in conducting clinical trials.
- Specifically, they must have had at least three innovative drug clinical trial applications approved, either within or outside China.
- Applicants are required to perform comprehensive risk assessments and develop effective risk management plans before submitting their clinical trial applications.
2. Clinical trial institutions
Clinical trial institutions participating in the pilot must meet stringent criteria.
- Qualified as a national medical centre or national clinical medical research centre, having a well-established system for supporting clinical trial project establishment, ethical review, and contract review services.
- The principal investigator (PI) must have led and completed at least three clinical trials of innovative new drugs and be capable of participating in the risk assessment and reviewing of clinical project protocols .
Implementation Steps and Timeline
The implementation of the pilot program will follow a structured process.
- Eligible regions must apply to the NMPA to participate in the pilot.
- Once a region is approved, clinical trial institutions within that region can apply to participate, provided they have established the necessary work systems.
- Applicants can submit their clinical trial projects to the provincial drug supervision and management department for review.
- If approved, the project will be included in the pilot, and the NMPA’s Center for Drug Evaluation (CDE) will complete the review and approval within 30 working days.
- The clinical trial is initiated within 12 weeks following approval of the clinical trial application.
The pilot program will be conducted over one year and mid-term evaluations will take place in January 2025. By July 2025, the program aims to have completed the review and approval of clinical trial applications for at least 10 drug varieties within the pilot regions.
Approval of Beijing and Shanghai as Pilot Regions
In a related development, the NMPA has approved Beijing and Shanghai as the first regions to participate in this pilot program. This approval is a significant milestone, given the strong pharmaceutical industry presence and research capabilities in these cities.
Further information
Read the original announcement on Innovative Drug Clinical Trial Approvals Pilot Program.
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