国外处方药与非处方药转换管理制度的研究及对我国的启示

目的：研究美国、欧盟和日本在非处方药转换管理中的管理理念、要素、具体的风险管控措施， 为完善我国非处方药转换管理提供借鉴。方法：对美国、欧盟和日本的非处方药转换管理制度进行了梳理，并从转换标准、申报路径、转换程序和资料要求等角度进行对比分析。结果与结论：这些国家或地区的转换管理规定和具体做法上存在着差异，但在管理理念和风险管控措施方面有很多共同之处，值得借鉴。

Research on Foreign Rx-to-OTC Switch Management System and Its Implication for China

Objective: To study the management philosophy, elements and specific risk control measures of the Rx-to-OTC switch management in the United States, the European Union and Japan, so as to provide reference for the improvement of the Rx-to-OTC switch management in China. Methods: To sort out Rx-to-OTC switch management system of the United States, the European Union and Japan, and to conduct a comparative analysis from the perspectives of converting standards, application paths, procedures and data requirements. Results and Conclusion: There are differences in the Rx-to-OTC switch regulations and specific practices among these countries or regions, but there are a lot in common in terms of management philosophy and risk control measures that are worthwhile drawing on.