Post-marketing requirements of the US accelerated approval and European conditional marketing authorization during 2015-2020
Objectives:To describe and compare the characteristics of the specific post-marketing requirements of the US accelerated approval(AA)and European conditional marketing authorization(CMA)from January 1,2015 to December 31,2020.Methods:The characteristics of all the drugs approved through AA and CMA pathway and their specific post-marketing requirements during the study phase were collected and analyzed.Results:From 2015 to 2020,the US FDA approved 122 and EMA approved 35 drugs and their indications(DAIs)through the AA/CMA pathway.For each DAI on average,the US FDA required 1.2 specific post-marketing requirements,and EMA required 2.3 specific post-marketing requirements(P<0.001).Most of the aims of US FDA's specific post-marketing requirements were to confirm the efficacy of the DAI(61.5%),while EMA's were to confirm both the efficacy and safety(85.7%).Surrogate endpoints were asked to be the primary endpoint for the post-approval confirmatory studies in most DAIs(AA,54.9%;CMA,61.8%).Intervention was required by 95.1%and 88.2%,randomization was required by 77.9%and 61.8%,and control was required by 63.1%and 67.7%for the post-approval confirmatory studies on the DAIs.The average time slot for submission of post-approval confirmatory studies was 46.8 months for AA and 37.5 months for CMA,with 31.6%and 21.9%DAIs had a time slot more than five years.Conclusion:EMA is more cautious and conservative than the US FDA on the specific post-marketing requirement.For the post-approval confirmatory studies,both US FDA and EMA required randomized controlled trials for most of the DAIs,however there were an overuse of surrogate endpoints.The average time slot for submission of post-approval confirmatory studies was within five years.Experience and lessons from US FDA and EMA could be learned to improve the conditional approval policy in China.
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