欧美与亚洲国家药品监管机构开展药品风险沟通的研究

Drug Risk Communication among Drug Regulatory Agencies in the European Union,the United States and Asia

目的分析亚洲国家药品监管机构开展药品风险沟通的现状,对比欧美国家相关内容与形式,为构建我国药品风险沟通模式提供参考。方法查阅国内外文献,检索亚洲各国药品风险沟通相关的法律法规及指南规范,浏览亚洲各国药品监管机构官方网站等,了解相关机构设置、沟通渠道、发布内容、开展形式等,同时对比欧美药品风险沟通情况。结果欧美国家及地区的药品风险沟通体系较为完善;东亚及东南亚一些国家已经意识到药品风险沟通的重要性,构建了较为及时、有效的风险沟通模式。结论建议我国进一步加强药品风险沟通体系构建,保障人民安全合理用药。

Objective To provide reference for the establishment of modes of drug risk communication in China by analyzing the current ways of drug risk communication in Asian countries,and by comparing the related contents and forms in China with those of the European Union and the United States.Methods By reviewing domestic and foreign literature,retrieving the guidelines,specifications,laws and regulations related to drug risk communication in Asia,browsing the official websites of drug regulatory authorities and other websites in Asia,information on related institutions,laws and regulations,communication channels,information released,and ways of development was harvested.Results The system of drug risk communication in Europe and the United States was relatively perfect.Some countries in East Asia and Southeast Asia became aware of the importance of drug risk communication and constructed effective modes of drug risk communication.Conclusion The construction of drug risk communication systems Could be strengthened to guarantee safe and rational drug use.