美国非处方药专论制度改革分析及对我国的启示--基于社会性规制均衡视角

Analysis of American OTC Monograph Reform and Its Enlightenment to China from the Perspective of Social Regulation Equilibrium

目的:对美国2020年开展实施的非处方药专论制度改革相关内容进行分析,为在我国探索实施非处方药专论提供参考。方法:查阅美国联邦法律、指南文件及国内外文献等,全面梳理美国非处方药专论的发展历程与改革内容,从目标均衡、供需均衡和工具均衡三方面分析美国非处方药专论改革特点,进而对我国实施非处方药专论提出相关建议。结果:美国非处方药专论改革通过实施行政令程序和制定《非处方药专论使用者付费法案》,提高美国食品药品监督管理局专论处理效率、鼓励企业提出创新,改革优化了美国非处方药管理规制在保护健康和促进创新两方面的均衡。结论:建议我国可基于社会性规制均衡视角考虑非处方药注册的监管规制,在探索实施非处方药专论过程中应用风险管理理念、关注企业诉求、逐步放开非处方药管理力度、加强激励工具的开发等。

Objective To analyze the system reform of American OTC monograph implemented in 2020,and provide reference for the exploration and implementation of OTC monographs in China.Methods The development process and reform content of A-merican OTC monograph were analyzed by reviewing American federal laws,guide documents and domestic and foreign literature,and the characteristics of the reform were analyzed from three aspects of target equilibrium,supply and demand equilibrium and tool equilibrium.Results The American OTC monograph reform has improved the approval efficiency of FDA and encouraged enterprises to promote innovation through administrative order and OMUFA,and has optimized the balance between protecting health and promoting innovation.Conclusion It is suggested to reform Chinese OTC registration process from the perspective of social regulation equilibrium,apply the concept of risk management,pay attention to the enterprises' demands,gradually liberalize the management of OTC drugs,and strengthen the development of incentive tools.