The State Council Office recently issued the "Opinions on Comprehensive Deepening the Reform of Drug and Medical Instruments Regulation to Promote High-Quality Development of the Pharmaceutical Industry." It optimizes the clinical trial review and approval mechanism. Provincial drug regulatory departments submit applications, and after the State Drug Administration's approval, a pilot program to optimize the review and approval process for Innovative Drugs clinical trials will be conducted in some areas, reducing the review and approval time from 60 working days to 30 working days. The clinical trial review and approval timeframe for medical instruments will also be reduced from 60 working days to 30 working days. The mechanism for the filing of bioequivalence trials will be optimized. The review and approval process for supplementary applications for Pharmaceuticals will be improved. Provincial drug regulatory departments submit applications, and after the State Drug Administration's approval, a pilot program to reform the review and approval procedures for supplementary applications for Pharmaceuticals will be conducted in some areas, reducing the timeframe for supplementary applications requiring verification from 200 working days to 60 working days. The management of Active Pharmaceutical Ingredient will be optimized, and the registration entity for Active Pharmaceutical Ingredient can be legally changed.
国办:在部分地区开展优化创新药临床试验审评审批试点 将审评审批时限由60个工作日缩短为30个工作日
The State Council Office: A pilot program to optimize the review and approval process for Innovative Drugs clinical trials will be carried out in some areas, reducing the review and approval time from 60 working days to 30 working days.
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