“药妆品”全球监管情况以及对我国的启示  

The Worldwide Regulation of Cosmeceutical and Its Enlightenments to China

作　　者：苏哲[1] 邢书霞[1] 王钢力[1] Su Zhe;Xing Shuxia;Wang Gangli(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国药事》2019年第12期1383-1390,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:梳理全球范围内"药妆品"监管情况,并对我国政府监管和行业发展提出建议。方法:选取化妆品生产和消费的主要国家或地区作为研究对象,如欧盟、美国、日本、韩国、加拿大等。通过对我国以及上述国家或地区的化妆品定义、相关产品分类、是否承认"药妆品"等情况进行研究比对,对其中容易造成错误理解的概念进行阐释,结合近年来相关问题的监管手段及监管趋势进行分析,总结出适合我国国情的监管建议。结果:通过研究比对,"药妆品"概念不符合大多数国家或地区关于"化妆品"的定义及相关法规要求,监管部门对此持相对谨慎态度,并采取了多种监管手段。结论:"药妆品"在全球范围内基本不具有合法地位,我国监管部门应继续保持打击力度,加强上市后监督检查;同时,进一步规范产品分类和功效宣称,积极引导整个行业长期健康发展。Objective:To analyze the worldwide regulation of"cosmeceutical"and to put forward suggestions for government regulation and industry development in China.Methods:Countries or regions which are the major producers and consumers were chosen as objects,including the European Union,America,Japan,Korea,Canada,etc..Definitions of cosmetics,classifications of related products and official attitudes towards"cosmeceutical"in these countries or regions and China were investigated and compared,some ambiguous concepts were clarified,regulatory measures and trends of related problems in recent years were analyzed in order to summarize some regulatory advice suitable for China.Results:According to this study,the concept of"cosmeceutical"does not meet the definition and related regulatory requirements of cosmetics in most countries or regions.Regulatory authorities are relatively conservative on"cosmeceutical"and have adopted various regulatory measures.Conclusion:The"cosmeceutical"basically does not have a legal status worldwide.Regulatory authorities in China should keep the strict administration and strengthen post-marketing supervision and inspection.At the same time,product classification and efficacy claim of cosmetics should be further standardized so as to guide the longterm development of the whole industry.

关 键 词：药妆品 化妆品 药品 医药部外品 定义 分类 监管 

分 类 号：R95[医药卫生—药学]