国内外化妆品不良反应监管动态与企业实践

doi:10.3969/j.issn.2097-2806.2026.05.014

Abstract

Abstract:

Post-marketing surveillance （PMS） is a critical component of risk management throughout the entire product lifecycle of cosmetics. As a core element of PMS, cosmetovigilance has emerged as a central approach and a key pillar of regulatory systems both domestically and internationally. This review summarizes the regulatory frameworks and operational mechanisms for cosmetovigilance in the European Union, the United States, Japan, and China. Furthermore, two international renowned cosmetic companies were selected as case studies to demonstrate how they developed their internal PMS systems and benefits derived from them. The aim is to provide insights and references for domestic cosmetic companies to actively respond to regulatory requirements, fulfill their legal obligations, and enhance their internal cosmetovigilance systems.

Key words: cosmetics, adverse reaction, surveillance, regulation

CLC Number:

TQ658

Manru Ning, Yihuai Liang, Feifei Wang. Cosmetovigilance: regulatory trends and corporate practices across countries[J].China Surfactant Detergent & Cosmetics, 2026, 56(5): 674-680.

Figures/Tables 3

References 24

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国家/地区	AE报告时限	SAE报告时限	法规条款	提交途径	格式要求
欧盟	非强制	20个自然日	SUE Reporting Guidelines第 2.4.3节	欧洲化妆品门户系统（CPNP）	SUE Form A/B/C
美国	非强制	15个工作日	《化妆品监管现代化法案》（MoCRA）第 6059节	MedWatch系统	MedWatch 3500A表格
日本	30个自然日	15个自然日	《药品、医疗器械等品质、有效性及安全性确保施行规则》第228条第20项第1号	PMDA（医药品医疗器械综合机构）在线报告系统	《医药部外品及化妆品不良反应症状报告书》
中国	30个自然日	15个自然日	《化妆品不良反应监测管理办法》第23条	国家化妆品不良反应监测系统	参考《化妆品不良反应报告表填写指南》（2022）

Cosmetovigilance: regulatory trends and corporate practices across countries

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