关键词: font-size:medium, ">合规管理；药品注册；历史演进

Abstract: 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.

Key words: font-size:medium, ">Compliance management； Drug registration； Historical evolution