药品临床试验默示许可:困局与突破  

Implied License of Drug Clinical Trials:Functional Orientation and Regulatory Innovation

作　　者：王晓淑 Wang Xiaoshu

机构地区：[1]中国政法大学法学院,北京100088

出　　处：《湖湘法学评论》2023年第2期68-78,共11页HUXIANG LAW REVIEW

基　　金：国家社会科学基金重大项目:中国特色国家监察理论构建、制度创新与实践运行研究(18ZDA135)。

摘　　要：《药品管理法》第19条第1款将药品临床试验从过去的审批许可制改为默示许可制,不仅提高了临床试验的审批效率,加速了候选药品的临床开发,更快地为患者带来了创新型药品,而且是对《行政许可法》中申请延续默示许可的延拓。但同时需要注意的是,受试者的生命安全和身体健康远高于科学研究及其背后的社会利益,若仅为追求研发效率的提高,而忽略对药品临床试验的实质审查义务,则会本末倒置,产生严重侵害受试者生命健康权的后果。《行政许可法》与《药品管理法》必须确定药品临床试验默示许可的边界,强化行政许可程序的约束,确保事中事后监管的有效实施。药品临床试验默示许可制度将调治行政许可理论中的痼疾,成为行政许可制度发展的新起点。The first paragraph of Article 19 of the Drug Administration Law changed drug clinical trials from the past approval system to an implicit permission system,which improves the approval efficiency of clinical trials,accelerates the clinical development of drug candidates,brings innovative medicines to patients faster,also extends the development of“application for renewal of implied license”in the Administrative License Law.But at the same time,it is important to note that the life safety and physical health of the subjects are much higher than the scientific research and social interests.If we only pursue the improvement of the research and development efficiency and ignore the obligation of substantive review of drug clinical trials,it would put the cart before the horse,resulting in serious violation of the subjects’rights on life and health.The Administrative License Law Relevance and the Drug Administration Law must clearly define the boundaries of implied licenses for drug clinical trials,strengthen the constraints of administrative licensing procedures,ensure the effective operation of supervision during and after the event.The implied license system for drug clinical trials will cure the chronic disease of administrative licensing theory,and become a new starting point for the development of the administrative licensing system.

关 键 词：默示许可 药品管理法 药品临床试验 正当程序 

分 类 号：D912.1[政治法律—宪法学与行政法学]