China’s NMPA Seeks Public Feedback on New Draft to Expedite Approval of Clinically Urgent Overseas Drugs

Medicine And Poison Pharma

On June 25, 2024, the National Medical Products Administration (NMPA) released a draft for public consultation titled “Announcement on Further Optimizing the Drug Review and Approval of Clinically Urgent Overseas Drugs.” This initiative aims to expedite the market entry of urgently needed overseas drugs in China, addressing critical medication needs and updating existing regulations to enhance access to essential medications.

Key highlights from the draft include:

  • Prioritized Review and Approval: Focus on original innovative drugs, chemical generics, and biosimilars to facilitate faster access to the Chinese market.
  • Optimized Review Process: Enhanced communication with the NMPA for utilizing domestic and international clinical data, potentially waiving local clinical trial requirements with comprehensive supporting materials.
  • Separate Management by CDE: The Center for Drug Evaluation (CDE) will manage applications for priority review drugs, providing guidance throughout the research and development process.
  • Improved Inspection System: Streamlined timelines for sample testing and standard review, particularly for rare disease drugs.
  • Enhanced Registration Verification: Integration of risk assessment with post-marketing overseas inspections.
  • Facilitated Temporary Import Channels: Continuous improvement of processes to meet the urgent medication needs of medical institutions, especially for rare diseases.

Impact Assessment:

  • Deadlines: Feedback should be submitted by July 24.
  • Impact: This draft facilitates faster access to the Chinese market for overseas drugs, particularly benefiting original innovative drugs, chemical generics, and biosimilars.
  • Next Steps: Companies should prepare comprehensive clinical trial data and supportive materials to demonstrate no ethnic differences, potentially waiving local clinical trial requirements. Engaging with the NMPA for drugs deemed clinically urgent, especially for rare diseases, is highly recommended.
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