摘要
目的:为我省探索建立高效、科学的化妆品审评和检查技术体系,形成更规范的进口普通化妆品备案审评管理制度提供依据。方法:收集了广东省自2018年3月~2020年4月日已经在国家药品监督管理局(以下简称国家局)进口普通化妆品备案管理系统取得备案凭证号的产品数据进行统计、汇总分析,找到目前化妆品备案中的常见问题,分析问题的原因,并提出建议。结果:备案资料整理阶段较为常见的是产品标签、产品执行标准、产品配方问题,备案后资料核查阶段较为常见的问题是产品执行标准、产品配方、产品检验报告问题。建议国家局尽快制定审评标准,统一审评尺度,用于提高办事的透明度和可预期性,降低审评、检查过程的技术风险;建议企业加强法规学习,强化企业落实主体责任能力及自觉遵守法规意识;建议国家局有计划、分阶段、有针对性地对各省化妆品备案审评人员开展培训,努力提高从业人员素质,提高审评的效率;建议国家局建立反馈机制,用于加强省局与国家局、省局与企业之间的沟通。
Objective:to provide a basis for our province to explore and establish an efficient and scientific cosmetic review and inspection technology system and form a more standardized filing,review and management system for imported ordinary cosmetics.Methods:the product data of Guangdong Province that has obtained the Filing Certificate number in the import general cosmetics filing management system of the State Drug Administration(hereinafter referred to as the National Bureau)from March 2018 to April 2020 were collected for statistics,summary and analysis,so as to find the common problems in the current cosmetics filing,analyze the causes of the problems,and put forward suggestions.Results:the common problems in the filing data sorting stage were product label,product executive standard and product formula.The common problems in the data verification stage after filing were product executive standard,product formula and product inspection report.It is suggested that the National Bureau should formulate evaluation standards and unify evaluation criteria as soon as possible,so as to improve the transparency and predictability of affairs and reduce the technical risks in the process of evaluation and inspection;It is suggested that enterprises strengthen the study of laws and regulations,strengthen the ability of enterprises to implement their main responsibilities and consciously abide by laws and regulations;It is suggested that the National Bureau of cosmetics carry out training for cosmetics record reviewers in all provinces in a planned,phased and targeted manner,strive to improve the quality of employees and improve the efficiency of review;It is suggested that the National Bureau establish a feedback mechanism to strengthen the communication between the Provincial Bureau and the National Bureau,and between the Provincial Bureau and enterprises.
作者
李菲
梁杰康
吴生齐
陈坚生
Li Fei;Liang Jiekang;Wu Shengqi;Chen Jiansheng(Evaluation and Certification Center of Guangdong Drug Administration,Guangzhou 510080,China)
出处
《广东化工》
CAS
2021年第24期60-61,共2页
Guangdong Chemical Industry
基金
广东省药品监督管理局科技创新立项资助项目(2019YDZ27)。
关键词
进口
普通化妆品
备案
问题
建议
import
ordinary cosmetics
keep on record
problems
proposal
