《药品管理法》中药物警戒制度实施的思考

On the Implementation of Pharmacovigilance System in the Drug Administration Law

目的:新修订的《中华人民共和国药品管理法》首次引入建立药物警戒制度,原有的不良反应监测和报告制度已不能满足我国药品监管的要求,需要从法规层面和实际操作层面整体设计。方法:通过查阅国内外文献,WHO、FDA和EMA网站等,比较分析WHO、美国和欧盟的药物警戒制度。结果与结论:对比WHO、美国和欧盟的药物警戒制度发现,我国的药物警戒制度处在刚刚起步阶段,本文从法律法规框架、科学监管体系、建立专业数据库以及加强药品上市许可持有人报告等方面提出了建议和意见。

Objective:The Drug Administration Law of the People’s Republic of China(2019 edition) introduces the establishment of the pharmacovigilance system for the first time.The current adverse reaction monitoring and reporting system in China can no longer meet the requirements of the regulation of drugs in China,which requires an overall design from the level of regulation and practical operation.Methods:The pharmacovigilance systems of WHO,United States and European Union were compared and analyzed by searching literature and the websites of WHO,FDA,EMA,etc.Results and Conclusion:Compared with the pharmacovigilance systems of WHO,United States and European Union,China’s pharmacovigilance system is still in its infancy.This paper puts forward suggestions and opinions from the following aspects:framework of laws and regulations,scientific regulation system,establishment of professional databases,and enhancement of the report of drug listing license holders.