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 Informationon Cosmetic Safety in China

作　　者：陈晰 吕笑梅 田少雷 CHEN Xi;LYU Xiaomei;TIAN Shaolei(Center for Food and Drug Inspection of NMPA,Beijing,China 100044)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100044

出　　处：《中国药业》2023年第24期25-29,共5页China Pharmaceuticals

摘　　要：目的为完善《化妆品安全高风险信息“直通车”检查制度(试行)》(简称《“直通车”制度》)提供参考。方法分析现场检查、监督抽检、风险监测、不良反应监测、投诉举报等监管环节[职能分属国家药品监督管理局(简称国家药监局)不同技术支撑机构]对化妆品安全风险信息的监测管理情况,以及《“直通车”制度》建立前存在的问题;基于风险管理理念(包括风险的识别、分析、评价、应对)建立国家药监局《“直通车”制度》,并运用于化妆品飞行检查实践。结果飞行检查动因更加集中于检出禁用原料严重超标等高风险情形;飞行检查中检查出的严重缺陷项在缺陷总数中占比由低于30%升至50%,发现缺陷项最多的环节由厂房设施与设备管理环节(27.68%)转为物料与产品管理环节(27.14%)。结论国家药监局《“直通车”制度》的建立与实施初步取得成效,建议进一步拓宽安全高风险信息收集途径,推动多部门联合开展风险分析评价,扩展制度适用范围,加强制度顶层设计,以改进和完善该制度。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 

分 类 号：R95[医药卫生—药学]