Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (2): 188-192.
DOI: 10.19803/j.1672-8629.20240621

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Current Progress and Considerations in Updating the Safety Information in Labels of Chinese Traditional Patent Medicines

ZHU Lan1, SHAO Bo1, ZHU Yan2, DAI Jie3, ZHONG Shiqi4   

  1. 1Center for Drug Reevaluation, NMPA/ NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    2Institute of Information on Traditional Chinese Medicine, CACMS, Beijing 100700, China;
    3Shaanxi Center for ADR Monitoring, Xi'an Shaanxi 710065, China;
    4Center for Drug Reevaluation, Guiyang Guizhou 550081, China
  • Received:2024-08-19 Online:2025-02-17 Published:2025-02-17

Abstract: Objective To review Current status of updating safety information in labels of Chinese traditional patent medicines. Methods To analyze the guidelines and requirements for the updating of information on adverse reactions, contraindications, precautions and warnings information in the labels of Chinese traditional patent medicines, and to make suggestions based on working experience. Results For some historical reasons, safety information is missing from some Chinese traditional patent medicine labels and should be added to provide guidance to healthcare professionals and patients on the use of medicines. Conclusion Revision of labeling and updating of safety information is one of the risk management measures, after solving the problem of missing safety information, there is still a need for continuous monitoring of adverse reactions, post-marketing research to identify drug risks, and to control the risks by revising labels and other measures.

Key words: Chinese Traditional Medicine, Labels, Safety Information, Adverse Drug Reaction, Contraindications, Precautions

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