美国化妆品安全性评价概况及启示

发布时间：2018-04-22 18:19

本文选题：化妆品 + 不良反应　；参考：《中国药房》2015年19期

【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。
[Abstract]:Objective: to provide reference for monitoring adverse reaction of cosmetics in China. Methods: from the legal basis, the definition concept, the safety data source and the limitation, the possible measures and so on, this paper introduces the cosmetic safety evaluation work carried out by FDA in the United States, and reports the adverse reactions of cosmetics in the United States. The processing steps of the report form and the role of the report are introduced. Results & conclusion: according to the Food, Drug and Cosmetics Act and the Fair Packaging and labelling Act, the United States FDA defines the scope of cosmetic administration, and through the voluntary registration plan of enterprises, the FDA carries out inspection and product investigation. Cosmetic safety data are monitored by cosmetic review expert group assessment and reports from consumers and health care workers, while adverse reaction reports are reported on a voluntary basis. In contrast to the present situation in China, we should improve the monitoring of adverse reactions of cosmetics from the aspects of revising and perfecting laws and regulations, defining the scope of monitoring, establishing the mechanism of inter-departmental cooperation and enhancing the transparency of work.
【作者单位】：江苏省药品不良反应监测中心;国家食品药品监督管理总局药品评价中心;南京中医药大学经贸管理学院;江苏省药学会;
【分类号】：R951

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