China drug approvals of clinically urgent overseas drugs proposal has been drafted for comments by the National Medical Products Administration (NMPA). The aim is to accelerate the availability of clinically urgent drugs that are already marketed abroad in China. This draft is now open for public comment until July 24, 2024.
Key Points of the Announcement:
1. Prioritizing Clinical Value:
- The NMPA encourages the marketing authorization of clinically urgent drugs that are already available abroad, including innovative drugs, chemical generics, and biosimilars. Eligible drugs may receive priority review and approval. This approach is guided by the clinical value these drugs provide.
2. Streamlined Review Mechanism:
- Applicants can now engage in communication with the Drug Evaluation Center regarding the utilization of both domestic and international clinical data. By submitting comprehensive clinical trial materials, applicants may be exempted from conducting new drug clinical trials. This can significantly shorten the time to market. Decisions on whether additional trials are necessary will be made within 30 days of application acceptance. Drugs meeting the criteria for priority review will undergo expert evaluation to determine their eligibility for this accelerated process.
3. Improved Testing Procedures
- For rare disease drugs not yet available in China, applicants are encouraged to use pre-registration testing.
- The timeframe for registration testing is reduced, and the sample quantity required is specified for efficiency: If only sample testing is needed, the testing duration will be shortened from 60 to 40 days. For cases where both standard review and sample testing are required, the timeframe will be decreased from 90 to 70 days. The quantity of samples required for testing will be twice the amount necessary for standard quality tests of a single commercial-scale batch.
4. Enhanced Registration Verification:
- The verification process for priority drugs will be optimized.
- Risk-based post-marketing inspections will be integrated with overseas checks to ensure thorough monitoring.
5. Facilitated Temporary Import Channels:
- The temporary import process for rare disease drugs will be further streamlined.
- This ensures rapid and efficient access for medical institutions to meet urgent clinical needs.
Quality compliance managers should note that the NMPA aims to strengthen the entire lifecycle management of these drugs. The goal is to ensure that clinically urgent overseas drugs can be swiftly and safely introduced to the Chinese market, meeting the critical needs of patients.
Stakeholders are invited to provide their feedback using the provided format by the specified deadline. This collaborative effort is essential for refining the approval process and ensuring the rapid availability of vital medications.
How to submit comments:
If you have any suggestions, comments or improvements, please send the feedback table and relevant materials to hxypc@nmpa.gov.cn with subject “Feedback on Optimizing Review and Approval of Clinically Urgent Overseas Drugs” before July 24, 2024.
Further information
Read the original NMPA announcement on China drug approvals of clinically urgent overseas drugs– draft for comments.
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