中国香港特别行政区与大陆药品不良反应监测体系的比较

摘要

Objective To introduce the specificity of ADR monitoring system in Hong Kong,and to comparatively analyze the differences between the ADR monitoring systems performed in Chinese Hong Kong and mainland,so as to propose the constructive suggestions and comments for improvements on the works in Chinese mainland.Methods In order to investigate laws and regulations of drug administration and ADR monitoring system in Hong Kong,we apply the methods inc1uding:local area investigations and professional conferences on subject discussions,in combination with the studies on data mining in research publications and website news reports.Results Existences of simplifier organization structure for ADR monitoring and suitable to the local drug supervision and administration system,together with effective information for ADR monitoring,were found in Hong Kong.Conclusion It has reference value from Hong Kong in the part of mechanism for drug supervision and administration system,and to raise the constructive proposals for the improvements on realization of responsibility for business administrations,the collections of severe ADR data and the consolidations on the legal and regulation systems in mainland.%目的 通过介绍香港药品不良反应(ADR)监测系统的特点,分析对比中国香港特别行政区和大陆ADR监测体系的不同.方法 采用实地走访调研座谈、结合文献检索和搜索相关网站信息的方法,了解香港药品监管法规和ADR监测体系.结果 香港具有较为精简的ADR监测组织架构,适合本地的药品监管体系和较为有效的ADR监测信息.结论 香港药品监管机制在加强企业责任、严重的ADR信息收集、完善法规制度等方面做法值得参考.