美国化妆品不良反应监测制度研究及启示

doi:10.19803/j.1672-8629.2021.12.10

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (12): 1148-1149.
DOI: 10.19803/j.1672-8629.2021.12.10

美国化妆品不良反应监测制度研究及启示

朱盈, 沈璐^*, 李岚, 孔繁瑶, 吴建民

国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022

收稿日期:2021-05-31 出版日期:2021-12-15 发布日期:2021-12-16
通讯作者: ^*沈璐,女,硕士,副主任药师,化妆品不良反应监测。E-mail: shenlu@cdr-adr.org.cn
基金资助:
朱盈,女,硕士,主管药师,化妆品不良反应监测

A Study on the American Cosmetics Adverse Reaction Monitoring System

ZHU Ying, SHEN Lu^*, LI Lan, KONG Fanyao, WU Jianmin

Center for Drug Reevaluation, NMPA/ NMPA Keg latorarorg for Research and Evaluation of Pharmacovigilance, Beijing 100022, China

Received:2021-05-31 Online:2021-12-15 Published:2021-12-16

摘要/Abstract

摘要： 目的研究美国化妆品不良反应监测制度与体系,为建立和完善我国化妆品不良反应监测制度和体系提供借鉴。方法通过查阅美国法律法规及相关文献研究,系统分析美国化妆品不良反应监测制度与体系。结果美国通过丰富化妆品不良反应报告途径、促进行业自律、数据公开等方式,提升化妆品不良反应监测水平,促进社会共治。结论建议借鉴美国化妆品不良反应监测工作经验,完善我国化妆品不良反应监测制度和体系建设。

关键词: 化妆品, 不良反应, 美国, 监测制度

Abstract: Objective To provide reference for the establishment and improvement of China's cosmetic adverse reaction monitoring system by studying the American cosmetic adverse reaction monitoring system.Methods The American cosmetics adverse reaction monitoring system was analyzed by consulting American laws and regulations and related literature. Results The monitoring level of cosmetic adverse reactions in the United States was improved and social co-governance was enhanced by diversifying reporting channels and promoting self-discipline and data disclosure in the industry.Conclusion The experience of American cosmetics adverse reaction monitoring is of positive significance for promoting the construction and improvement of China's cosmetics adverse reaction monitoring system.

Key words: cosmetics, adverse reaction, America, monitoring system

中图分类号:

R951

朱盈, 沈璐, 李岚, 孔繁瑶, 吴建民. 美国化妆品不良反应监测制度研究及启示[J]. 中国药物警戒, 2021, 18(12): 1148-1149.

ZHU Ying, SHEN Lu, LI Lan, KONG Fanyao, WU Jianmin. A Study on the American Cosmetics Adverse Reaction Monitoring System[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1148-1149.

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美国化妆品不良反应监测制度研究及启示

A Study on the American Cosmetics Adverse Reaction Monitoring System

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