基于行政法视角的药物临床试验机构备案管理监管挑战  

Regulately challenges in filing management of drug clinical trial institutions from perspective of administrative law

作　　者：李秀丽 谢建林 胡晨希 LI Xiu-li;XIE Jian-lin;HU Chen-xi(Center for Food and Drug Inspection of National Medical Products Administration,BEIJING 100076,China;Center for Inspection of Jiangsu Medical Products Administration,Nanjing JIANGSU 210009,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100076 [2]江苏省药品监督管理局审核查验中心,江苏南京210009

出　　处：《中国新药与临床杂志》2024年第9期661-665,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：为探索药物临床试验机构备案制后监管部门的日常监管策略,本文基于行政法的视角,分析药物临床试验机构资格认定与备案管理的区别及备案管理的特点,并联系实践探讨当前备案制下药物临床试验机构监管部门面临的调整和应对措施。备案制简化了药物临床试验机构获得资格的时限,细化了药物临床试验机构的准入标准,突出了机构及研究者的资格要求及主体责任,对事后监管提出了更高的要求。监管要求的更新和监管数量的增加,要求监管部门严格检查标准,转变执法理念,创新监管方式,强化风险控制,不断提高监管水平,从而助力我国建设高质量的药物临床试验机构。To explore the daily regulatory strategies of regulatory authorities after the implement of filing system of drug clinical trial institutions.From the perspective of administrative law,this article analyzes the differences between the qualification recognition and filing management of drug clinical trial institutions,as well as the characteristics of filing management,and explore the adjustments and response measures for regulatory authorities of drug clinical trial institutions under the current filing system through practice.The filing system simplifies the time limit for drug clinical trial institutions to obtain qualifications,refines the admission standards for drug clinical trial institutions,highlights the qualification requirements and main responsibilities of institutions and researchers,and puts forward higher requirements for post-supervision.The update of regulatory requirements and the increase in regulatory quantity require regulatory authorities to strictly inspect standards,transform law enforcement concepts,innovate regulatory methods,strengthen risk control,and continuously improve regulatory levels,thereby to help China build high-quality drug clinical trial institutions.

关 键 词：药物临床试验机构 备案 行政法 监管 

分 类 号：R951[医药卫生—药学]