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中国医药导刊 ›› 2025, Vol. 27 ›› Issue (7): 660-665.

• 监管科学 • 上一篇    下一篇

从风险控制视角探讨化妆品检查与稽查的有效衔接

喻文娟1, 游延军1, 王誉蒨1, 李汀2, 周涵1*, 刘俊文1, 王新3, 廖豪1   

  1. 1.四川省药品技术检查中心,四川 成都 610020;

    2.四川省药品监督管理局,四川 成都 610031;

    3.黑龙江省药品监督管理局,黑龙江 哈尔滨 150001
  • 收稿日期:2025-02-10 修回日期:2025-04-03 接受日期:2025-10-10 出版日期:2025-07-28 发布日期:2025-10-10

Discussion on the Effective Coordination between Cosmetics Inspection and Law Enforcement Investigation from the Perspective of Risk Control

YU Wenjuan1, YOU Yanjun1, WANG Yuqian1, LI Ting2, ZHOU Han1*, LIU Junwen1#br# WANG Xin3, LIAO Hao1   

  1. 1.Sichuan Technical Inspection Center for Medical Products Sichuan Chengdu 610020, China
    2.Sichuan Medical Products Administration Sichuan Chengdu 610031,China
    3.Heilongjiang Provincial Drug Administration Heilongjiang Haerbin 150001, China
  • Received:2025-02-10 Revised:2025-04-03 Accepted:2025-10-10 Online:2025-07-28 Published:2025-10-10
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摘要:

目的:分析全国化妆品检查与稽查执法衔接机制的建设现状及存在的问题,提出完善化妆品检查与稽查执法衔接工作机制的对策建议,以提升监管效能。方法:基于国家药品监督管理局官网数据、问卷调研结果、法规政策及文献研究,系统梳理全国化妆品检查与稽查执法的执行主体模式、资源配置、制度规范及实践问题,并探讨加强化妆品检查与稽查执法有效衔接的工作建议。结果:据调研发现当前全国71%的省份由检查机构执行化妆品检查工作,但仅6%省份的检查机构承担化妆品稽查职能,导致线索移交及稽查执法需要跨部门衔接协作;但目前化妆品检查员普遍缺乏稽查能力,证据移交存在规范性不足、时限不统一等问题,且双向反馈机制缺失,影响衔接效率。结论:《化妆品检查管理办法》的出台,明确了化妆品检查与稽查执法衔接相关内容。建议从制度建设、能力提升、流程细化、信息化支撑四方面完善衔接机制:统一各省检查与稽查标准及文书模板;加强检查员证据采集能力与稽查人员技术检查培训;明确线索移交时限与分类响应机制;构建信息共享平台实现智慧监管。通过强化协同联动,促进化妆品检查与稽查执法深度融合,强化化妆品质量安全风险防控能力。


关键词: 化妆品检查, 稽查, 衔接, 问题, 建议

Abstract:

Objective: To analyze the current situation and existing challenges of the linkage mechanism of cosmetics inspection and law enforcement investigation in China and put forward countermeasures and suggestions to improve the coordination of cosmetics inspection and relevant enforcement so as to enhance the efficiency of supervision.Methods: Based on the data from the official website of the National Medical Products AdministrationNMPA), the results of questionnaire survey study on relevant regulations and literature this study systematically sorted out the main operation model resource allocation system norms and practical challenges in the coordination between cosmetics inspection and law enforcement investigation nationwide and proposes suggestions for optimizing the operational linkage between cosmetics inspection and law enforcement investigation.Results: According to survey findings currently 71% of the provinces nationwide have inspection agencies responsible for conducting cosmetics regulatory inspections. However only 6% of provincial cosmetics inspection agencies are authorized to perform investigative enforcement functions necessitating cross-departmental coordination and collaboration for handover of invesigative leads and enforcement actions. Critical challenges include widespread deficiencies in inspectors' investigative capabilities non-standardized evidentiary handover protocols inconsistent timelines and the absence of a two-way feedback mechanism all of which collectively impair the operational efficiency of regulatory enforcement coordination.Conclusion: The promulgation of Measures for the Administration of Cosmetics Inspection has established explicit provisions regarding the coordination mechanism between cosmetics inspections and relevant enforcement. It is suggested to enhance the linkage mechanism from the aspects of institutional framework development capacity building process refinement and informationization support harmonize inspection and relevant enforcement standards and documentation templates intra-provincial jurisdictions strengthen evidence collection competencies of inspectors and provide technical inspection training for enforcement personnel define statutory timeframes for investigative leads handover and implement categorized response protocols establish an integrated information-sharing platform to realize intelligent supervision. By reinforcing collaborative synergy between cosmetics inspection and enforcement entities facilitate deep integration of cosmetics inspection with law enforcement investigation thereby enhancing risk prevention and control capabilities for cosmetics quality and safety.

 

Key words:  , Cosmetics inspection , Law enforcement investigation , Coordination , Challenges , Suggestions

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