In a move aimed at accelerating the approval process for clinically urgent overseas drugs, China's National Medical Products Administration (NMPA) has drafted a new announcement titled "Notice on Further Optimizing the Review and Approval of Clinically Urgent Overseas Drugs (Draft for Public Comment)." The NMPA is now seeking public feedback on this notice and stakeholders are encouraged to submit their comments to the email address [email protected] by July 24, 2024.
The notice outlines several key measures to enhance the marketing approval process for clinically urgent overseas drugs:
1. Clinical Value-Oriented Approach: The notice encourages the marketing approval of clinically urgent overseas drugs in the Chinese market, including original drugs, generic chemical drugs, and biosimilars. Such drugs can be included in the priority review list, provided they meet the specified requirements.
2. Optimized Review Mechanism: The notice proposes a faster review process. Applicants can engage in communication with the NMPA's Center for Drug Evaluation (CDE) regarding the use of clinical data from both domestic and international trials and priority review matters. They can submit a comprehensive set of clinical trial documents, literature, international multi-center trial data, and supporting materials showing no racial differences. Following successful discussions with the CDE, drug clinical trials can be exempted, allowing for direct marketing approval applications. For drugs requiring clinical trials, a decision on whether to proceed will be made within 30 days of application receipt. Applications meeting the criteria for priority review will be expedited. The CDE will independently manage the registration of clinically urgent overseas drugs within the priority review category, providing enhanced communication and guidance throughout the entire R&D and application process.
3. Enhanced Testing System: For rare disease drugs that are clinically urgent and not yet available domestically, the notice encourages the application of pre-registration testing. If only sample testing is required, the testing period will be reduced from 60 to 40 days. If both standard review and sample testing are required, the period will be reduced from 90 to 70 days. The sample volume for testing will be set at twice the amount needed for quality standard tests for one commercial-scale batch.
4. Streamlined Registration Verification: For drugs included in the priority review category, the notice aims to optimize the initiation of overseas registration verification. Overseas registration verification can be aligned and integrated with post-marketing overseas inspections according to risk evaluations.
5. Facilitated Temporary Import Channels: The notice emphasizes maintaining smooth temporary import channels for clinically urgent overseas drugs, particularly for rare diseases.
