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中国医药导刊 ›› 2023, Vol. 25 ›› Issue (1): 101-104.

• 智慧监管 • 上一篇    下一篇

中药追溯体系建设现状与建议

  李桂桂   

  1. 国家药品监督管理局信息中心, 北京 100044
  • 收稿日期:2022-10-24 修回日期:2023-03-06 出版日期:2023-01-28 发布日期:2023-01-28

Current Situation and Suggestions on Traceability System of Chinese Materia Medica

Gui guiLi   

  1. Information Center of NMPA, Beijing 100044, China
  • Received:2022-10-24 Revised:2023-03-06 Online:2023-01-28 Published:2023-01-28

摘要: 目的:促进我国中药追溯体系的完善,达到中药“来源可知、去向可追、质量可查、责任可究”,保障公众用药安全。方法:通过分析当前国内中药质量追溯体系建立的现状与难点,针对性地提出实质性建议。结果和结论:鉴于目前中药追溯平台搭建成本高、推广不足,追溯监管主体多元、法律制度不完善等情况可能还存在于现行的中药追溯体系,我国中药追溯体系的建立现仍处于研究和起步阶段,但是在中药的质量安全、中药材流通现代化和中药产业发展的强烈需求下,建立完善健全的中药追溯体系的目标势在必行。本研究提出了几条可行性建议,致力于逐步建立中药“从生产到消费”的质量可追溯体系。

关键词: font-size:medium, ">中药追溯;追溯质量;用药安全;中药材;中药饮片

Abstract: Objective:To promote the improvement of the traceability system of Chinese materia medica in China, so as to ensure the safety for public use and achieve the goal of knowing the source, whereabouts, quality and responsibility. Methods:Based on analyzing the current situation and difficulties of establishing the quality traceability system of Chinese meteria medica, substantive suggestions were put forward. Results and Conclusion:In view of the high cost and insufficient promotion of the traceability platform of Chinese meteria medica, the diversity of traceability supervision subjects and the imperfect legal system may still exist in the current traceability system of traditional Chinese medicine. The construction of Chinese materia medica system in China is still in the research and initial stage, but under the strong demand of the quality and safety of Chinese materia medica, the modernization of traditional Chinese medicine circulation and the development of traditional Chinese medicine industry, it is imperative to establish a sound Chinese materia medica traceability system. This paper puts forward some feasible suggestions to gradually establish the quality traceability system of traditional Chinese medicine from production to consumption.

Key words: font-size:medium, ">Traceability of Chinese materia medica; Traceability quality; Medication safety; Chinese medicinal materials; Chinese herbal pieces

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