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国家药监局:探索实现30个工作日内完成创新药临床试验申请审评审批,缩短药物临床试验启动用时

National Medical Products Administration: Explore completing the review and approval of clinical trial applications for innovative drugs within 30 working days, shortening the time to start clinical trials.

Breakings ·  Jul 31 18:54

The National Medical Products Administration has issued a notice on the pilot program for streamlining the clinical trial review and approval of innovative drugs. The notice requires optimizing the mechanism for clinical trial review and approval of innovative drugs, strengthening the primary responsibility of clinical trial applicants, improving the ability of stakeholders of clinical trials of innovative drugs to identify and manage risks, exploring the establishment of a comprehensive system and mechanism to improve the quality and efficiency of drug clinical trials, achieving completion of the clinical trial application review and approval for innovative drugs within 30 working days, and shortening the time to initiate drug clinical trials.

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