Progress in the implementation of China's drug conditional approval system and some suggestions
Objective:To provide reference for the improvement of the conditional approval system and the smooth implementation of related work in China.Methods:Through literature research and data statistics,the implementation of China's conditional approval system was described in terms of indications,accelerated review time,clinical trials,post-marketing requirements,and inclusion in medical insurance,problems existing in the implementation of the system were analyzed,and suggestions for improvement were put forward.Results:Conditional approval of drugs was dominated by anti-tumor drugs;conditional approval could expedite the marketing of clinically urgently needed drugs with outstanding clinical value;phase Ⅱ single-arm trials with objective remission rate(ORR)as an endpoint metric accounted for the highest proportion of pivotal clinical trials supporting conditional approval;post-marketing studies included pharmacological and real-world studies in addition to confirmatory clinical studies;inclusion in health insurance was essentially the same as for routinely approved innovative drugs.Conclusion:In order to promote the smooth implementation of conditional approval of drugs in China,it is still necessary for the regulatory authorities to continuously improve the relevant regulations,supporting systems,organizations and their functions.
conditional approval for marketingconditional approvaldrugs
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