我国药品和医疗器械关联审评审批制度对化妆品原料管理和产品安全评价的启示  

Associated Evaluation and Approval of Drugs and Medical Devices in China and the Inspiration for Cosmetic Ingredient Management and Cosmetics Safety Evaluation

作　　者：苏哲[1] 何淼 胡康[1] 张凤兰[1] 余振喜[1] 王钢力[1] 路勇[1] Su Zhe;He Miao;Hu Kang;Zhang Fenglan;Yu Zhenxi;Wang Gangli;Lu Yong(National Institutes for Food and Drug Control,Beijing 100050,China;Department of Cosmetics Regulation,National Medical Products Administration,Beijing 100037,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]国家药品监督管理局化妆品监督管理司,北京100037

出　　处：《中国药事》2023年第2期150-156,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:研究我国药品、医疗器械关联审评审批相关制度,为化妆品原料管理和产品安全评价提供参考。方法:对近年来国家药品监督管理部门发布的药品、医疗器械关联审评审批政策进行梳理总结,对相关监管要求和技术管理手段进行分析,并与化妆品监管要求和管理现状进行对比。结果与结论:在考虑行业差异和监管差异的基础之上,可参考借鉴我国药品和医疗器械关联审评审批相关制度和配套措施,优化我国化妆品审评审批流程、划清安全责任界限、加强原料信息管理、借助信息化支撑手段,探索“化妆品原料安全信息库”的科学应用,提高化妆品原料管理和产品安全评价的整体效率。Objective:To study the regulations about associated evaluation and approval of drugs and medical devices in China,so as to provide references for the management of cosmetic ingredients and product safety evaluation of cosmetics.Methods:The policies associated with evaluation and approval of drugs and medical devices issued by the National Medical Products Administration(or the former China Food and Drug Administration)in recent years were summarized.The relevant regulatory requirements and technical management measures were analyzed,and compared with the current situation of cosmetic regulatory requirements and management.Results and Conclusion:On the basis of considering the industry and regulatory differences,the relevant systems and supporting measures of related evaluation and approval of drugs and medical devices in China could be referenced.For cosmetics,the evaluation and approval process could be optimized,the safety responsibility borderlines should be further defi ned,the management of cosmetic ingredient information should be strengthened,and the use of information support means should be further developed.The scientifi c application of the“Cosmetic Ingredient Safety Information Database”was explored,and the overall effi ciency of cosmetic ingredient management and product safety evaluation could be improved.

关 键 词：药品 医疗器械 关联审评审批 化妆品 原料 安全评价 

分 类 号：R95[医药卫生—药学]