我国药品风险管理计划和药物警戒计划的研究概况

Overview of drug risk management plan and pharmacovigilance plan in China

我国的《药物警戒质量管理规范》对药物警戒计划的定位是药品上市后风险管理计划的一部分,与欧盟风险管理计划的理念存在差异。我国将风险管理计划按照上市前后不同阶段进行了区分,上市前称为“临床风险管理计划”,批准上市后将其转化为“药物警戒计划”,而欧盟的风险管理计划关注的一直是药品的临床使用风险,没有进行上市前后的区分。由于我国提出风险管理计划的理念较晚,在早期时很多有药品出口业务的企业当时多数是以欧盟的风险管理计划为参考制定的,所以当我国再提出上市后风险管理计划要求时,很多人会有概念上的混淆。结合欧盟和我国近年来对药品风险管理计划的要求变化,厘清药物警戒计划和风险管理计划之间的区别和联系,以期帮助企业更好地开展上市后风险管理。

The positioning of pharmacovigilance plans in the "Good Quality Management Practice for Pharmacovigilance" is a part of the post-marketing risk management plan(RMP) of drugs,which differs from the concept of the EU's RMP.In China,RMP are differentiated according to different stages before and after marketing.Before marketing,they are referred to as "clinical risk management plans",and after approval for marketing,they are converted into "pharmacovigilance plans." However,the EU's RMP has always focused on the clinical use risks of drugs,without distinguishing between before and after marketing.Due to the late introduction of the concept of RMP in China,many enterprises engaged in drug export business in the early years were mostly based on the EU RMP.Therefore,when China again proposed requirements for a post-market RMP,many people would have conceptual confusion.Based on the changes in requirements for drug RMP in the EU and China in recent years,this article clarifies the differences and linkages between pharmacovigilance plans and RMP,to help enterprises correctly carry out post-marketing risk management.