中国药物警戒 ›› 2024, Vol. 21 ›› Issue (2): 219-222.
DOI: 10.19803/j.1672-8629.20230720

• 安全与合理用药 • 上一篇    下一篇

新法规体系下我国牙膏不良反应监测工作分析与思考

朱盈, 沈璐*, 李岚, 吴建民, 高晓洁   

  1. 国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室, 北京 100076
  • 收稿日期:2023-11-14 出版日期:2024-02-15 发布日期:2024-02-06
  • 通讯作者: *沈璐,女,硕士,副主任药师,化妆品不良反应监测。E-mail: shenlu@cdr-adr.org.cn.
  • 作者简介:朱盈,女,硕士,主管药师,化妆品不良反应监测。

Adverse reaction monitoring of toothpaste in China under the new regulatory system

ZHU Ying, SHEN Lu*, LI Lan, WU Jianmin, GAO Xiaojie   

  1. Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China
  • Received:2023-11-14 Online:2024-02-15 Published:2024-02-06

摘要: 目的 探讨《牙膏监督管理办法》正式施行后,在新法规体系下我国牙膏不良反应监测工作思路。方法 2023年3月16日,国家市场监督管理总局发布《牙膏监督管理办法》并于2023年12月1日正式施行。通过查阅文献及相关法规资料,梳理我国牙膏不良反应监测历史,结合监测工作现状及实践,分析当前牙膏不良反应监测工作存在的不足。结果 目前我国牙膏备案人不良反应监测工作能力还有待提高、主体报告意识还需要加强、监测人员监测水平还需提高、牙膏产品信息查询还不够便捷、公众对牙膏不良反应的认知水平还需进一步提升。结论 《牙膏监督管理办法》的颁布标志着我国牙膏不良反应监测工作的制度化、规范化、科学化,各相关方应当加强对新法规的理解和落实,加强报告单位及监测机构能力建设、加强新法规宣贯与监测技术指导、加强牙膏不良反应监测技术支撑体系建设、加强牙膏不良反应知识宣传,从而保障消费者的使用安全。

关键词: 化妆品, 牙膏, 不良反应, 监测, 牙膏监督管理办法

Abstract: Objective To explore ways in which adverse reactions of toothpaste in China should be monitored after the official implementation of Measures for Supervision and Administration of Toothpaste. Methods On March 16, 2023, the State Administration of Market Regulation issued the Measures for Supervision and Administration of Toothpaste, which came into force as of December 1, 2023. In this paper, the related literature and regulations were consulted while the history of adverse reaction monitoring of toothpaste in China was reviewed. Based on the current practices in adverse reaction monitoring, the loopholes in this area were analyzed. Results China’s ability to monitor toothpaste needs to be improved, the incentive to report adverse reactions related to toothpaste is lacking, information about toothpaste products is not easily accessible, and the public needs to be better informed of adverse reactions of toothpaste. Conclusion The implementation of Measures for Supervision and Administration of Toothpaste marks the institutionalization, standardization, and perfection of China’s adverse reaction monitoring of toothpaste. All parties concerned should enhance their interpretation and implementation of the new regulations, improve the quality of reporting and monitoring, make the new regulations better-known and provide technical guidance on monitoring, construct a better system of technical support for monitoring adverse reactions to toothpaste, and safeguard the safety of consumers.

Key words: cosmetics, toothpaste, adverse reactions, monitoring, Measures for Supervision and Administration of Toothpaste

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