中国药物警戒 ›› 2015, Vol. 12 ›› Issue (8): 483-486.

• 政策与法规研究 • 上一篇    下一篇

欧盟化妆品不良反应监测制度的研究与启示

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   

  1. 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
  • 收稿日期:2015-09-02 修回日期:2015-09-02 出版日期:2015-08-08 发布日期:2015-09-02
  • 通讯作者: 姚孝元,男,硕士·硕导,化妆品不良反应监测。E-mail:yaoxy@chinacdc.cn
  • 作者简介:孙波,男,硕士,副研究员,化妆品不良反应监测。

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

SUN Bo1, SHEN Lu2, GENG Li1, WANG Yan1, ZHU Wen-ling1, JIN Xin1, HAN Xu1, YAO Xiao-yuan1   

  1. 1. Institute of Environmental Health and Related Product Safety, China CDC, Beijing 10050, China;
    2. Centre for Drug Reevaluation, CFDA, Beijing10045, China
  • Received:2015-09-02 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

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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。

关键词: 不良反应, 化妆品, 欧盟

Abstract: 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.

Key words: undesirable effect, cosmetic, EU

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