药物警戒工作中常用关键术语定义及适用条件和范围  

Concepts,Applicable Conditions,and Scopes of Commonly Used Key Terms Related to Pharmacovigilance Work

作　　者：夏旭东 王丹 孙婷 孙阳 胡增峣 XIA Xudong;WANG Dan;SUN Ting;SUN Yang;HU Zengyao(Henan Drug Reevaluation Center,Zhengzhou,Henan,China 450004;Center For Drug Reevaluation,NMPA,Beijing,China 100076;Hebei Institute for Drug and Medical Device Control,Shijiazhuang,Hebei,China 050200;National Medical Products Administration,Beijing,China 100037)

机构地区：[1]河南省药品评价中心,河南郑州450004 [2]国家药品监督管理局药品评价中心,北京100076 [3]河北省药品医疗器械检验研究院,河北石家庄050200 [4]国家药品监督管理局,北京100037

出　　处：《中国药业》2025年第9期1-6,共6页China Pharmaceuticals

基　　金：河北省药品监督管理局科技计划项目[2022ZC1029]。

摘　　要：目的促进药物警戒工作的规范开展。方法通过梳理药物警戒工作中常用关键术语的定义,查阅相关法规条款和文献,并结合工作实践,对风险管理与风险控制,上市后研究与上市后评价,风险管理计划与药物警戒计划,药品群体不良事件与药品不良反应聚集性事件这4组术语的适用条件、适用范围进行解析。结果与结论每组术语虽然名称相似、内涵相近,存在一定关联性,但在实践工作中的适用条件和范围存在一定差异。建议正确理解其关联性和差异性,确保药物警戒工作规范化地开展。Objective To promote the standardized implementation of pharmacovigilance work.Methods By clarifying the concepts of commonly used key terms in pharmacovigilance work,reviewing relevant regulatory provisions and literature,and combining with work practice,the applicable conditions and scope of four sets of terms were analyzed:risk management and risk control,post-marketing research and post-marketing evaluation,risk management plan and pharmacovigilance plan,drug group adverse events and drug adverse reaction aggregation events.Result and Conclusion The terms in each group have similar names and connotations,and have a certain degree of correlation,but there are some differences in the applicable conditions and scopes in practical work.It is recommended to have a correct understanding of their correlation and differences to ensure standardized implementation of pharmacovigilance work.

关 键 词：风险管理 风险控制 上市后研究 上市后评价 风险管理计划 药物警戒计划 药品群体不良事件 药品不良反应 

分 类 号：R95[医药卫生—药学]