中国药业2023，Vol.32Issue(24)：25-29,5.DOI:10.3969/j.issn.1006-4931.2023.24.006
我国化妆品安全高风险信息"直通车"检查制度探讨与实践
Exploration and Practice of the Express Route Inspecton System for High-Risk Information on Cosmetic Safety in China
陈晰 1吕笑梅 1田少雷1
作者信息
- 1. 国家药品监督管理局食品药品审核查验中心,北京 100044
- 折叠
摘要
Abstract
Objective To provide a reference for improving the Express Route Inspection System for High-Risk Information on Cosmetic Safety(trial,hereinafter referred to as the Express Route System).Methods The monitoring and management of cosmetic safety risk information in various regulatory processes such as on-site inspection,supervision and sampling inspection,risk monitoring,adverse reaction monitoring,complaint and tip-off[belonging to different technical support agencies of the National Medical Products Administration(NMPA)]and the problems in the previous monitoring and management system were analyzed.Based on the concept of risk management(including risk identification,analysis,evaluation and response),the NMPA Express Route System was established and applied to the cosmetic unannounced inspection.Results The reasons for the unannounced inspection were mainly high-risk events such as the detection of over-standard prohibited materials.The proportion of serious defective items in total found in the unannounced inspection increased from<30%to 50%.The process with the most defective items changed from factory facility and equipment management(27.68%)to material and product management(27.14%).Conclusion The establishment and implementation of the NMPA Express Route System has obtained initial success.It is suggested that we should expand the collection channels of high-risk safety information,promote the joint risk analysis and evaluation among multiple departments,expand the application scope of systems and strengthen the top-level design to perfect the Express Route System.关键词
化妆品/安全/风险/监管/"直通车"/制度/现场检查Key words
cosmetic/safety/risk/regulation/express route/system/on-site inspection分类
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陈晰,吕笑梅,田少雷..我国化妆品安全高风险信息"直通车"检查制度探讨与实践[J].中国药业,2023,32(24):25-29,5.
