中国药业2025，Vol.34Issue(9)：1-6,6.DOI:10.3969/j.issn.1006-4931.2025.09.001
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
摘要
Abstract
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Key words
risk management/risk control/post-marketing research/post-marketing evaluation/risk management plan/pharmacovigilance plan/drug group adverse events/adverse drug reactions分类
医药卫生引用本文复制引用
夏旭东,王丹,孙婷,孙阳,胡增峣..药物警戒工作中常用关键术语定义及适用条件和范围[J].中国药业,2025,34(9):1-6,6.基金项目
河北省药品监督管理局科技计划项目[2022ZC1029]. （）
