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
Key words
drug clinical trial institutions/filing/administrative law/supervision
维普
万方数据