从标准化角度浅谈如何做好国产普通化妆品备案工作

摘要：

【目的】从行政部门角度，发掘国产普通化妆品备案工作中存在的问题，并探索解决问题的方法。【方法】通过调研和实证研究，发现备案审查缺少专业性和规范性、技术核查与备案审查联动不充分、现场检查与技术核查协同不充分、法规理解缺少统一、自由裁量缺少约束和异地跨区审管衔接缺少规范统一。【结果】运用标准化的理念、方法和技术可以提升化妆品备案审查质量和政务服务水平，加强技术核查和备案审查联动，加强现场检查和技术核查协同，统一法规理解和规范自由裁量和加强监管队伍，做好异地审管衔接。【结论】建立覆盖全环节周期的国产普通化妆品备案标准化工作程序，可以成为做好备案工作的基础和保障，能有效克服当前分散管理导致的诸多问题。

Abstract:

[Objective] From the perspective of administrative departments, the paper explores the problems in the notification of domestic general cosmetics and the solutions. [Methods] Through investigation and empirical research, the study found the main problems are lack of professionalism and standardization in notification examination, insufficient linkage between technical assessment and notification examination, insufficient coordination between on-site inspection and technical assessment, lack of unified understanding of regulations, discretion and constraints, and lack of standardized and unified connection between notification and supervision and administration in different regions. [Results] The application of standardized concepts, methods, and technologies can improve the quality of notification examination and government service level, strengthen the linkage between technical assessment and notification examination, enhance the coordination between on-site inspection and technical assessment, unify the understanding and standardization of laws and regulations, strengthen regulatory teams, and strengthen the connection between notification and supervision and administration in different regions. [Conclusion] It is crucial to establish a standardized notification procedure for domestic general cosmetics that covers the entire process, which can become the foundation and guarantee for the work, and effectively overcome these main problems caused by current decentralized management. 

引用格式：王飞轩,濮兴超,曹阳,等.从标准化角度浅谈如何做好国产普通化妆品备案工作[J]. 标准科学,2025(3):113-119.

基金项目：本文受江苏省药品监督管理局药品监管科学研究计划项目“国产普通化妆品备案技术核查标准和工作程序项目”（项目编号：202242）资助。 

作者简介：王飞轩，通信作者，硕士，高级工程师，研究方向为化妆品备案、标准化。