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

摘要/Abstract

摘要：

化妆品上市后监管是产品全生命周期风险控制的重要环节，其中“化妆品警戒”作为核心手段，逐渐成为国内外监管体系中的关键组成。文章梳理了欧盟、美国、日本以及我国的化妆品不良反应监管法规与运行机制，并分析了国际知名企业在化妆品警戒领域的体系建设与实践经验，以期为我国化妆品积极响应监管要求、履行法规义务、完善内部化妆品警戒体系提供借鉴。

关键词: 化妆品, 不良反应, 监测, 法规

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

中图分类号:

TQ658

宁曼如, 梁艺怀, 王飞飞. 国内外化妆品不良反应监管动态与企业实践[J]. 日用化学工业（中英文）, 2026, 56(5): 674-680.

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

图/表 3

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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）