欧盟生物类似药的药物警戒计划及启示  

Pharmacovigilance Plan of Biosimilars in European Union and its Revalation

作　　者：郑丽娥[1] 王雅雯[1] 粟晓黎[1] 邹宇玲[1] 范玉明[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2016年第4期331-338,共8页Chinese Pharmaceutical Affairs

摘　　要：生物类似药批准后的安全监测即药物警戒,对于监测生物类似药及其参照药之间安全性信号的潜在差异是至关重要的方法。本文分析了欧盟生物类似药的药物警戒系统的要求,即上市批准申请必须提交一份风险管理计划及药物警戒计划。该药物警戒计划必须考虑在产品开发期间发现的风险,在产品批准后,应关注潜在风险和如何应对这些风险。希望本文提供的欧洲生物类似药药物警戒计划及相关工作的信息,能为更新国家的指导原则提供参考。The postapproval safety monitoring of biosimilars will be critical to detect potential differences in safety signals between a biosimilar and its reference product. This paper analyzes the the European Pharmacovigilance System requirements of biosimilars; the applicant of the biosimilar marketing authorization must submit a risk-management plan and pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product. We expect to provide some useful information in biosimilars pharmacovigilance plan and action in European in referring to the update national guidelines.

关 键 词：生物类似药 药物警戒 药物警戒计划 风险管理计划 欧盟 

分 类 号：R95[医药卫生—药学]