中国药物警戒 ›› 2021, Vol. 18 ›› Issue (9): 850-854.
DOI: 10.19803/j.1672-8629.2021.09.11

• 法规与管理研究 • 上一篇    下一篇

我国化妆品不良反应监测工作发展现状及思考

李岚, 孔繁瑶, 朱盈, 沈璐*   

  1. 国家药品监督管理局药品评价中心,药物警戒研究与评价重点实验室,北京 100022
  • 收稿日期:2020-09-29 出版日期:2021-09-15 发布日期:2021-09-18
  • 通讯作者: *沈璐,女,硕士,副主任药师,化妆品不良反应监测。Email: shenlu@cdr-adr.org.cn
  • 作者简介:李岚,女,硕士,主管药师,化妆品不良反应监测。

Developments and Suggestions on Cosmetics Adverse Reaction Monitoring in China

LI Lan, KONG Fanyao, ZHU Ying, SHEN Lu*   

  1. Center for Drug Reevaluation, Key Laboratory for Research and Evaluation of Pharmacovigilance, NMPA, Beijing 100022, China
  • Received:2020-09-29 Online:2021-09-15 Published:2021-09-18

摘要: 目的 分析我国化妆品不良反应监测工作的发展现状和问题。方法 对我国化妆品不良反应监测工作的历史进行总结,分析和探讨工作中存在的问题。结果 我国化妆品不良反应监测体系和系统已初步建成,化妆品监测工作正努力服务于监管,并从中挖掘科普宣传内容。结论 建议完善化妆品不良反应标准体系,加强监测体系建设并强化落实化妆品注册人和备案人的主体责任等,以推动我国化妆品不良反应监测工作深入开展。

关键词: 化妆品, 不良反应监测, 问题, 发展现状

Abstract: Objective To review the developments of and problems with cosmetics adverse reaction monitoring in China. Methods The history of cosmetics adverse reaction monitoring in China was reviewed and the existing problems were analyzed and discussed. Results The management system and monitoring system of cosmetics adverse reactions have been basically established. Professionals in cosmetics adverse reaction monitoring are working hard to serve supervision and popularize the related science. Conclusion It is recommended that the standard system of the cosmetics adverse reactions be improved, the monitoring system be strengthened and the responsibilities of cosmetics registrants and filing persons be fully implemented so as to boost the development of cosmetics adverse reaction monitoring.

Key words: cosmetics, adverse reaction monitoring, questions, development status

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