摘要
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。
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.
作者
陈震
邓万和
田春华
张彦彦
杨建红
陈宁
余美
黎泽琳
张象麟
Chen Zhen;Deng Wanhe;Tian Chunhua;Zhang Yanyan;Yang Jianhong;Chen Ning;Yu Mei;Li Zelin;Zhang Xianglin(School of Pharmaceutical Sciences,Zhengzhou University,Zhengzhou 450001,China;School of Yeehong Business,Shenyang Pharmaceutical University,Beijing 100055,China;Yang Sen R&D Center in China,Beijing 100025,China;National Center for ADR Monitoring,Beijing 110022,China;School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《中国药事》
CAS
2020年第11期1247-1254,共8页
Chinese Pharmaceutical Affairs
关键词
药品分类管理
非处方药
分类转换
风险管理
drug classification system
over-the-counter drug
Rx-to-OTC Switch
risk management
