Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (2): 219-222.
DOI: 10.19803/j.1672-8629.20230720

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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

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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