欧盟预防用疫苗药物警戒特殊要求及启示  

Specific Consideration and Enlightenment of Pharmacovigilance on Vaccine for Prophylactic Use in European Union

作　　者：董铎[1] 王亚丽[1] 王丹[1] 冯红云[1] 夏玉坤[1] 程刚[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药房》2014年第38期3553-3555,共3页China Pharmacy

基　　金：科技部"艾滋病和病毒性肝炎等重大传染病防治专项"之"传染病疫苗临床试验评价体系"课题的子课题"我国自主知识产权乙脑疫苗;甲肝疫苗安全性评价报告"(No.2012ZX10004-703)

摘　　要：目的:通过对欧盟预防用疫苗药物警戒特殊要求的介绍,为完善和发展我国疫苗不良反应报告和监测体系提供借鉴和参考。方法:对欧盟药品管理局官方网站有关药物警戒以及预防用疫苗特殊要求的文献资料进行分析研究。结果与结论:欧盟预防用疫苗药物警戒工作在风险管理系统、定期安全性更新报告、上市后安全性研究、信号管理、批次召回或封存等方面值得借鉴和参考,对于我国开展疫苗药物警戒的重要意义、风险管理、病例定义标准化以及安全性沟通等方面提出了思考和启示。OBJECTIVE： To provide reference for the improvement and development of vaccine-induced ADR reporting and monitoring system in China by introducing specific consideration of pharmacovigilance on vaccine for prophylactic use in EU. METHODS： The documents related to pharmacovigilance and specific consideration for vaccines in European Medicines Agency website were analyzed and studied. RESULTS ＆ CONCLUSIONS： It was worth learning from risk management system, periodic safety update report, post-authorisation safety studies, signal management, batch recall and quarantine, etc. The significance of vac- cine pharmacovigilance, risk management, standardization of case definition and safety communication calls for deep thought.

关 键 词：欧盟 药物警戒 疫苗 特殊要求 

分 类 号：R969.3[医药卫生—药理学] R186.2[医药卫生—药学]