欧盟化妆品不良反应监测制度的研究与启示  

Research and Its Revelations on the EU Cosmetic Adverse Reaction Monitoring System

作　　者：孙波[1] 沈璐[2] 耿莉[1] 王艳[1] 朱文玲[1] 金鑫[1] 韩旭[1] 姚孝元[1] 

机构地区：[1]中国疾病预防控制中心环境与健康环境相关产品安全所,北京100050 [2]国家食品药品监督管理局药品评价中心,北京10045

出　　处：《中国药物警戒》2015年第8期483-486,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的了解欧盟化妆品不良反应监测制度的内容与特点,对我国化妆品不良反应监测工作提供参考。方法从立法背景、立法进程和监管制度等方面对欧盟化妆品不良反应监测制度进行研究,并与我国化妆品不良反应监测制度进行对比分析。结果与结论欧盟化妆品不良反应的定义清晰、有关于严重不良反应的信息交流制度、信息保密制度和先进的关联性评价标准,有明确的后续措施和应对措施,以上对我国化妆品不良反应监测工作有一定的借鉴作用。Objective To understand the content and characteristics of the EU cosmetic undesirable effect monitoring system and to provide reference for cosmetic adverse reaction monitoring work in china. Methods The background, progress and characteristics of the EU cosmetic undesirable effect monitoring system were studied, the differences and relations were also analyzed. Results and Conclusion The EU system offers clear definitions of cosmetic undesirable effect and detailed provision on communication and countermeasures of serious undesirable effect with an advanced causality assessment standard, the related information is kept confidential. All mentioned above are of certain reference value to cosmetic adverse reaction monitoring work in china.

关 键 词：不良反应 化妆品 欧盟 

分 类 号：R965[医药卫生—药理学]