欧盟新版《药物警戒实践指南》解读  

Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union

作　　者：谢雁鸣[1] 田峰[2] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院博士后流动站,北京100700

出　　处：《中国中药杂志》2013年第18期2963-2968,共6页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030)

摘　　要：由于上市前临床试验的局限性,药品上市前研究所获得的安全性信息相对有限。在药品上市后开展药物警戒活动是非常必要的。为了更好地促进新的药物警戒法规的具体实施,欧盟药品管理局制定了新的《药物警戒实践指南》(guideline on good pharmacovigilance practices,GVP),作为欧盟药物警戒工作的新准则。与《人用医药产品药物警戒指南》相比较,GVP指南在药物警戒系统、质量体系、主文件、检查和监查方面提出了更全面系统的规定,在风险管理系统、药品不良反应的管理和报告、定期安全性更新报告、上市后安全性研究、信号管理等技术方面提出更具体和全面的要求。通过对GVP指南中的基本原则、工作机制、关键技术和方法进行初步的解读,可为笔者开展药物警戒(尤其是中药注射剂安全性监测)工作提供有益的借鉴。Due to the hmitations of pre-authorization chnical trials, the safety information obtained from them is relatively lim- ited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency （EMA） developed the Guideline on Good Pharmacovigilanee Practices （GVP）, as the new criteria for pharmacovigilance in the European Union （EU）. Compared with the pre- viously published, Guidelines on Pharnuwovigilance for Medicinal Products for Human Use （2007）, the GVP proposed more compre- hensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and repor- ting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance （especially regarding safety monitoring of parenterally administered Chinese medicine）.

关 键 词：欧盟 药物警戒 指南 

分 类 号：R95[医药卫生—药学]