欧盟、美国和日本的药物警戒信号管理体系比较研究

目的:比较欧盟、美国和日本的药物警戒信号管理体系,为建立和完善我国药物警戒信号管理体系提供参考。方法:采用文献研究分析法,系统对比欧盟、美国和日本的相关监管机构在药物警戒信号定义、来源、检测方法和管理流程等方面的异同,并对我国药物警戒管理工作提出建议。结果与结论:欧盟、美国和日本的监管机构对于信号的定义并不统一,欧盟药品管理局采用国际医学科学组织委员会第8工作组的定义,美国FDA采用自定定义,而日本监管机构未有明确定义;目前欧盟、美国和日本的药品上市后安全性监测仍主要依靠自发报告系统,且均已开展基于自发报告系统的信号检测,其中欧盟以比例报告比值比法为主,美国以多项伽马泊松分布缩减法为主,日本以报告比值比法为主;欧盟对于信号管理流程设有专门的指南,而美国和日本尚缺乏。建议我国应加快健全药物警戒法律法规体系,制定系统的药物警戒实践指南,加强药品不良反应主动监测,并推进数据挖掘方法在信号检测中的应用,以加速我国药物警戒工作的规范化、国际化进程。

Comparative Study on Pharmacovigilance Signal Management System among the European Union,the United States and Japan

OBJECTIVE:To provide reference for constructing and improving the pharmacovigilance signal management system in China by comparing signal management system among the European Union(EU),the United States(U.S.)and Japan.METHODS:Literature analysis method was used to systematically compare the similarities and differences on definitions,sources,detection methods and management process of pharmacovigilance signals among EU,U.S.and Japan.Some suggestions were put forward for pharmacovigilance management in China.RESULTS&CONCLUSIONS:Regulatory authorities of the EU,U.S.and Japan did not have a uniform definition on signals;EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences,FDA adopted its own definition,while the Japanese regulatory agency had no clear definition.Currently,post-marketing surveillance still relied mainly on spontaneous reporting systems;EU,U.S.and Japan had carried out the signal detection based on the spontaneous reporting system;EU mainly adopted the proportional reporting ratio method,U.S.mainly adopts the multiple gamma Poisson Shrinker,and Japan mainly adopted the reporting ratio method.EU had special guidelines for signal management process,while the U.S.and Japan did not.It is recommended to accelerate the development of the legal and regulatory framework on pharmacovigilance in China,draw up guidelines on pharmacovigilance practices,strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field,for accelerating the standardization and internationalization of China’s pharmacovigilance work.