我国药品研发主体在药品不良反应监测中责任缺失

Analysis on deficiency of R&D main body′s responsibility in adverse drug reaction monitoring in China

目的:引导相关部门重视药品研发主体在药品不良反应监测中的作用,为完善相关制度提供参考。方法:采用文献研究和比较研究的方法,研究国内外药品上市审批制度下研发主体对药品不良反应监测的职责。结果:当前我国研发主体对药品上市后安全性的关注义务被忽略,一定程度上阻碍了ADR隐患的及时发现;一些发达国家将药品生产许可和上市许可分离管理,强化了药品研发者对药品上市后监测的职责。结论:有关部门可以借鉴发达国家的经验,赋予药品研发者申请获得药品上市许可的权利,健全我国药品安全责任体系。

Objective： To induce relevant department attach importance on the RD main body′s responsibility in adverse drug reaction monitoring,and provide reference for improving relevant system and regulations.Methods： Study RD main body′s responsibility in adverse drug reaction monitoring both here and abroad under different drug marketing approval system by means of literature review and comparative analysis etc.Results： The RD main body′s obligation of monitoring post-marketing drug safety was ignored in China,and to some extent it might hinder the timely detection of potential ADR.The drug marketing approval system in some developed country separated the manufacturing approval and marketing approval,and made it obligate for RD main body to monitor adverse drug reaction,which can be use for reference.Conclusion： It′s necessity to draw on the experience of developed country,to make it legal for RD main body to apply for and obtain marketing approval,and to make a sound system of drug safety.