介紹歐洲藥品管理局（EMA）于2018年8月15日發(fā)布的"草藥產(chǎn)品或傳統(tǒng)草藥產(chǎn)品質(zhì)量指南（第3修訂版草案）"主要內(nèi)容。EMA的草藥及其產(chǎn)品的情況與我國中藥有相似之處，而我國目前尚未制定關(guān)于中藥或中藥材（飲片）的質(zhì)量研究相關(guān)指導(dǎo)原則，該指南相關(guān)質(zhì)量和穩(wěn)定性研究的指導(dǎo)思路可為中藥的質(zhì)量研究提供參考。

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.