中国药房Issue(19)：2604-2607,4.DOI:10.6039/j.issn.1001-0408.2015.19.04
美国化妆品安全性评价概况及启示
Brief Introduction and Revelation on the Safety Evaluation of US Cosmetics
孙骏 1沈璐 2李浩 3魏臻 4李明1
作者信息
- 1. 江苏省药品不良反应监测中心，南京 210002
- 2. 国家食品药品监督管理总局药品评价中心，北京 100045
- 3. 南京中医药大学经贸管理学院，南京 210023
- 4. 江苏省药学会，南京 210002
- 折叠
摘要
Abstract
OBJECTIVE:To provide reference for the ADR monitoring of cosmetics in China. METHODS:The cosmetics safe-ty evaluation carried out by the US FDA was introduced in aspects of legal basis,concept definition,safe data sources and limita-tions,and measures that can be taken,etc. And the report contents of adverse reactions,report form processing steps and the role of report were also introduced. RESULTS & CONCLUSIONS:The management scope of cosmetics in US FDA was defined by Food,Drug and Cosmetic Act and Fair Packaging and Labeling Act. Cosmetics safe data was monitored by voluntary registration scheme in enterprises,check conducted by FDA,product investigation,evaluation by cosmetic review panel,and report by con-sumers and health care workers,etc. And the adverse reactions were reported voluntarily. Compared with the present situation in China,the cosmetics monitoring should be improved in aspects of revising and improving the laws and regulations,defining the monitoring scope,establishing inter-sectoral linkages cooperation mechanisms and strengthening transparency in the work.关键词
化妆品/不良反应/安全性评价/监测Key words
Cosmetic/Adverse reaction/Safety evaluation/Monitoring分类
医药卫生引用本文复制引用
孙骏,沈璐,李浩,魏臻,李明..美国化妆品安全性评价概况及启示[J].中国药房,2015,(19):2604-2607,4.
