[1]闫钇岑,刘玮,田燕,等.从皮肤科视角看化妆品监管科学体系的发展与未来[J].中国皮肤性病学杂志,2021,(01):1-7502bc64-80b7-4347-a516-6ef265e8a47a/pdf.[doi:10.13735/j.cjdv.1001-7089.202004169]
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从皮肤科视角看化妆品监管科学体系的发展与未来
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《中国皮肤性病学杂志》[ISSN:1001-7089/CN:61-1197/R]

卷:
期数:
2021年01期
页码:
1-7502bc64-80b7-4347-a516-6ef265e8a47a/pdf
栏目:
专家论坛
出版日期:
2021-01-01

文章信息/Info

Title:
Development and Prospective of Cosmetic-related Regulatory Science:Views from Dermatologists
文章编号:
1001-7089(2021)01-0001-06
作者:
闫钇岑1刘玮2田燕2闫学会3吴艳1仲少敏1张宇4张修成4李航1
1.北京大学第一医院皮肤科,国家皮肤与免疫疾病临床医学研究中心,皮肤病分子诊断北京市重点实验室,北京100034;2.中国人民解放军空军特色医学中心,北京100142;3.北京市西城区市场监督管理局,北京100035;4.北京修成药业有限公司,北京100085
Author(s):
YAN Yicen1LIU Wei2TIAN Yan2YAN Xuehui3WU Yan1ZHONG Shaomin1ZHANG Yu4ZHANG Xiucheng4LI Hang1
1.Department of Dermatology,Peking University First Hospital,National Clinical Research Center for Skin and Immune Diseases,Beijing Key Laboratory of Molecular Diagnosis on Dermatoses,Beijing 100034,China; 2.Department of Dermatology,Air Force General Hospital of PLA,Beijing 100142,China; 3.Beijing Xicheng District Administration for Market Regulation,Beijing 100035,China; 4.Beijing Xiucheng Pharmaceutical Company Limited,Beijing 100085,China
关键词:
化妆品 监管科学 功效评价 不良反应监测 政策制定 皮肤科
Keywords:
Cosmetics Regulatory science Efficacy evaluation Adverse effect monitoring Regulation establishment Dermatology
分类号:
TQ 658; F 203
DOI:
10.13735/j.cjdv.1001-7089.202004169
文献标志码:
A
摘要:
建立法规和探索法规建立的指导原则是监管科学的重要领域。这决定了该学科必须依赖于法律、政治和价值观等社会学内容,也决定了它有别于源自实验室的研究科学。很多国家把化妆品与药品、医疗器械等一起纳入政府医药卫生监管体系,这体现了政府对化妆品行业的重视。然而,化妆品的应用人群和市场行为与药品和医疗器械具有显著差异,因此化妆品相关监管科学因其独特性而自成体系。化妆品监管科学的主要领域包括产品分类、政策制定、功效评价、安全性评价以及不良反应监测等。很多国家在化妆品监管过程中非常注重以皮肤科学为代表的临床学科的介入,并以医学视角,依托临床研究方法开展化妆品评价和监管。
Abstract:
Regulation establishment and its methods are important fields of regulatory science. This determines that regulatory science must depend on some fields of social science including law,politics,and common value,differing from experimental science originated from laboratories only. Due to the importance of cosmetics management,many governments supervise cosmetics together with drugs and medical devices. However,cosmetics regulatory science creates its own system since the user and market behavior of cosmetics are significantly different from drugs and medical devices. The focus areas for cosmetic regulatory science include product classification,regulation establishment,efficacy evaluation,and safety assessment. Many countries draw great support from clinical subjects represented by dermatology in cosmetic regulation. Meanwhile,clinical research methods are widely used in cosmetic evaluation and regulation.

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备注/Memo

备注/Memo:
[通信作者] 李航,E-mail:drlihang@126.com
更新日期/Last Update: 2021-01-10