美国药品注册合规管理历史演进探讨

Discussion on the Historical Evolution of Drug Registration Compliance Management in the United States

目的:探索与分析美国药品注册合规管理的历史演进规律。方法:在明晰药品注册合规、药品注册合规管理概念的基础上,系统分析美国药品注册合规管理的历史演进过程。结果:美国药品注册合规管理经过80多年的发展,形成了涵盖药品注册申请人和监管人员两大行为主体的合规管理体系。FDA针对药品注册申请人的合规管理逐渐由单一的执法演变为包括合规教育、合规指导、合规检查和执法多种举措并行的综合性管理。结论:为了确保药品的安全性与有效性,药品监管机构不仅需要加强对申请人的合规管理,还需要注重对监管人员的合规管理。药品监管机构仅依赖执法难以确保申请人主动合规,需要合规教育、合规指导、合规检查和执法多种合规管理举措的共同作用。"合规人人有责"的合规文化是促进申请人和监管人员主动合规的核心要素。

Objective:To explore and analyze the historical evolution of drug registration compliance management in the United States.Methods:Clarify the concepts of drug registration compliance and drug registration compliance management,and systematically analyze the historical evolution process of drug registration compliance management in the United States.Results:After more than 80 years of development,drug registration compliance management in the United States has formed a compliance management system that covers two main subjects of drug registration applicants and FDA supervisors.FDA′s compliance management for drug registration applicants has gradually evolved from enforcement to a comprehensive management that includes compliance education,compliance guidance,compliance inspection and enforcement.Conclusion:In order to ensure the safety and effectiveness of drugs,drug regulatory agency not only needs to strengthen the compliance management of applicants,but also needs to pay attention to supervisors.It is difficult for drug regulatory agency to ensure compliance of applicants depending on enforcement,and that a combination of compliance education,compliance guidance,compliance inspection,and enforcement is required.The compliance culture of“everyone is responsible for compliance”is a core element in promoting the voluntary compliance of applicants and supervisors.