[关键词]
[摘要]
介绍欧洲药品管理局(EMA)于2018年8月15日发布的"草药产品或传统草药产品质量指南(第3修订版草案)"主要内容。EMA的草药及其产品的情况与我国中药有相似之处,而我国目前尚未制定关于中药或中药材(饮片)的质量研究相关指导原则,该指南相关质量和稳定性研究的指导思路可为中药的质量研究提供参考。
[Key word]
[Abstract]
This article introduces the "guideline on quality of herbal medicinal products/traditional herbal medicinal products (draft revision 3)" issued by European Medicines Agency (EMA) in August 5, 2018. At present, China has not established relevant guidance for the quality research of traditional Chinese medicine (TCM) or Chinese herbal medicine (Chinese herbal pieces).The situation of EMA's herbal medicine and its products is similar to that of Chinese traditional medicine, and the study on its quality and stability can provide a reference for the quality research of Chinese traditional medicine.
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