摘要
目的:为我国药品附条件批准上市制度的完善和相关工作的顺利实施提供参考.方法:通过文献研究和数据统计,从适应证、加速审评时间、临床试验、上市后要求、纳入医保情况等方面阐述我国药品附条件批准上市制度的实施情况,分析制度实施过程中存在的问题,并提出改进建议.结果:附条件批准上市药物以抗肿瘤药为主;附条件批准可加快具有突出临床价值的临床急需药品上市;支持附条件批准的关键临床试验中以客观缓解率为终点指标的Ⅱ期单臂临床试验占比最高;上市后研究除确证性临床研究外还包括药学研究、真实世界研究等;纳入医保情况与常规批准的创新药基本相同.结论:为推动我国附条件批准上市制度的顺利实施,仍需要监管部门不断完善相关法规、配套的制度、组织机构及职能.
Abstract
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.
基金项目
2020年辽宁省教育厅科学研究经费资助项目(2020WJC02)
NETL
NSTL
万方数据