回应性监管理论在我国药品安全监管模式中的应用

The application of responsive regulatory theory in China′s drug safety regulatory model

目的探讨回应性监管理论在我国目前药品安全监管模式中的应用,为后续我国药品安全监管模式的进一步发展提供参考依据。方法以起源于西方国家的回应性监管理论为依据,通过研究其三个理论基础、理论的主体内容、衍生理论等方面,分析该理论的内在实质,在研究我国目前的药品安全监管现状后,总结出几个典型问题,并尝试将回应性监管理论应用于我国的药品安全监管实际中来。结论尽管回应性监管理论起源于公共管理学科,该理论仍然可以在药品安全监管体制中发挥原则上的指引作用,为后续完善药品安全监管的模式提供理论方面的参考依据。

Objective To discuss the application of responsive regulation in the current drug safety regulatory model in China,and to provide reference for its further development.Methods Based on the theory of responsive regulation in western countries,we studied three theoretical bases,main content of theories,and their derivative theories so that we could analyze their inner essence.After investigating the current situation of drug safety supervision in China,we summarized several typical problems,and attempted to apply the theory of responsive regulation to the practice of drug safety regulation in China.Conclusion Although the theory of responsive regulation originated from the discipline of public management,it can still play an important role in the drug safety supervision system,which will provide theoretical reference for the follow-up improvement of drug safety supervision mode.