我国化妆品智慧审评技术要点分析

doi:10.3969/j.issn.1001-1803.2022.10.012

摘要/Abstract

摘要：

为落实《化妆品监督管理条例》,国家药品监督管理局构建了全新的化妆品法规和技术体系,并组织建设化妆品注册备案信息服务平台,中国食品药品检定研究院积极开展了化妆品智慧审评相关工作。论文在此基础上,以《化妆品监督管理条例》及其配套法规为依据,围绕电子资料内容和技术审评工作要求,对能够通过系统完成一定自动化判定和提示的审评要点进行梳理,对具体实现路径、需整合数据库、判断逻辑等进行分析,并讨论了在技术审评和监管工作中的应用。目前,已成功建立起一系列智慧审评要点,覆盖产品配方和原料使用、产品检验报告、产品标签样稿、产品执行的标准、安全评估报告等审评内容,并研究了功效宣称评价依据摘要的规范化填报和自动形式审核,为化妆品智慧审评和智慧监管工作提供了技术支撑。

关键词: 化妆品, 监督管理条例, 化妆品智慧申报审评系统, 智慧审评

Abstract:

In order to implement the Regulations on the Supervision and Administration of Cosmetics, the National Medical Products Administration has established new regulations and technical systems and organized the construction of a cosmetics registration and filing information service platform. The National Institutes for Food and Drug Control has carried out research on the intelligent evaluation of cosmetics. In this study, based on the Regulations on the Supervision and Administration of Cosmetics and its supporting regulations, the contents of the registration or filing documents and the concerns in technical evaluation work, the researchers summarized the key points that could be automatically detected and reviewed by the IT system, analyzed the technical path, databases to be integrated, and logic rules, and discussed the possible application in technical evaluation and supervision. So far, a series of key points for intelligent evaluation of cosmetics have been established, covering product formula and ingredient use, product test reports, product label, product implementation standard and safety evaluation report, and a standardized filling and automatic formal examination of the abstract of efficacy claim evaluation has also been developed. This work will provide technical support for intelligent evaluation and supervision of cosmetics in China.

Key words: cosmetics, CSAR, ECSIE, intelligent evaluation

中图分类号:

TQ658

苏哲,胡康,吕冰峰,塔娜,王钢力,路勇. 我国化妆品智慧审评技术要点分析[J]. 日用化学工业（中英文）, 2022, 52(10): 1113-1120.

Su Zhe,Hu Kang,Lv Bingfeng,Ta Na,Wang Gangli,Lu Yong. Technical key points of intelligent evaluation of cosmetics in China[J]. China Surfactant Detergent & Cosmetics, 2022, 52(10): 1113-1120.

图/表 4

参考文献 15

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