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

作　　者：孙骏[1] 沈璐[2] 李浩[3] 魏臻[4] 李明[1] 

机构地区：[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

出　　处：《中国药房》2015年第19期2604-2607,共4页China Pharmacy

摘　　要：目的:为我国开展化妆品不良反应监测工作提供参考。方法:从法律依据、定义概念、安全性数据来源及局限性、可采取的措施等方面介绍美国FDA开展的化妆品安全性评价工作,并对美国化妆品不良反应的报告内容、报告表处理步骤和报告发挥的作用进行介绍。结果与结论:美国FDA依据《食品药品化妆品法案》和《公平包装及标签法》法案对化妆品的管理范围加以界定,通过企业的自愿注册计划,FDA开展的检查、产品调查,化妆品审查专家组评估以及消费者与卫生保健人员的报告等途径对化妆品的安全性数据进行监控,不良反应报告采取自愿报告方式。对比我国现状,应该从修改完善法律法规、界定监测范围、建立部门间联系合作机制以及增强工作透明度等方面改进化妆品不良反应监测工作。OBJECTIVE：To provide reference for the ADR monitoring of cosmetics in China.METHODS：The cosmetics safety evaluation carried out by the US FDA was introduced in aspects of legal basis,concept definition,safe data sources and limitations,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 consumers 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 

分 类 号：R951[医药卫生—药学]