博鳌乐城国际医疗旅游先行区特许药械政策实施研究与分析

Research and Analysis on the Implementation of Exclusively Licensed Drugs and Medical Devices Policies in Lecheng Pilot Area of Boao International Medical Tourism

目的:为研究者和监管部门在特许药械政策制度建设方面提供参考建议。方法:对近年来国家及海南省政府针对乐城先行区特许药械政策及实施情况进行总结,分析乐城先行区特许药械全流程监管模式,探讨新发展形势下面临的挑战。结果与结论:基于近四年的探索,海南省已建立一套行之有效、全面完善的乐城模式特许药械监管体系,但未来还需在风险防控、制度建设、医疗服务体系等方面继续细致深化。

Objective:To provide reference and suggestions for researchers and regulatory authorities in the construction of policies and systems of exclusively licensed drugs and medical devices.Methods:A series of policies and implementation of exclusively licensed drugs and medical devices formulated by the state and Hainnan government in recent years were summarized.The whole process supervision mode of exclusively licensed drugs and medical devices in Lecheng Pilot Area were analyzed,and the challenges under the new development situation were discussed.Results and Conclusion:Based on nearly four years of exploration,a set of effective and comprehensive supervision systems of exclusively licensed drugs and medical devices in Lecheng Pilot Area have been established.In the future,it needs to continue to carefully deepen the risk prevention and control,system construction and medical service system in Hainan.