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國家藥監局:探索30個工作日內完成創新藥臨床試驗申請審評審批

National Medical Products Administration: Explore completing clinical trial application review and approval for innovative drugs within 30 working days.

AASTOCKS ·  Aug 1 07:36

The National Medical Products Administration issued a notice entitled 'Optimization and Innovation of Clinical Trial Evaluation and Approval Pilot Work Program for Innovative Drugs', proposing to optimize the clinical trial evaluation and approval mechanism for innovative drugs, strengthen the main responsibility of drug clinical trial applicants, enhance the risk identification and management capabilities of stakeholders in drug clinical trials regarding innovative drugs, explore the establishment of a comprehensive work system and mechanism to improve the quality and efficiency of drug clinical trials, and achieve the goal of completing the evaluation and approval of clinical trial applications for innovative drugs within 30 working days, and promote the target of shortening the start-up time of drug clinical trials in pilot areas.

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