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National Medical Products Administration: Streamlining the Review and Approval Process for Overseas Drugs Already on the Market That Are Urgently Needed Clinically
According to the National Medical Products Administration (NMPA), in order to expedite the domestic market launch of urgently needed overseas-marketed drugs and meet patients’ urgent clinical needs, the NMPA has further optimized the review and approval process for such drugs. The NMPA stated that it will adhere to a clinical value-oriented approach and encourage applicants to conduct global simultaneous R&D and submit applications for market authorization in China; It also encourages the submission of applications in China for urgently needed original and generic drugs that are already marketed overseas, and those that meet the requirements may be included in the scope of priority review and approval. For urgently needed rare disease drugs that are marketed overseas but not yet available in China, applicants are encouraged to apply for registration testing through the pre-submission testing approach. For applications involving only sample testing, the registration testing timeline is reduced from 60 days to 40 days; for applications involving both standard review and sample testing, the timeline is reduced from 90 days to 70 days. (CCTV News)
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