草藥及其產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)具有區(qū)別于化學(xué)藥品或生物制品的特殊性，因此歐洲藥品管理局（EMA）于2018年發(fā)布了“質(zhì)量標(biāo)準(zhǔn)指南：草藥物質(zhì)、草藥制劑和草藥產(chǎn)品或傳統(tǒng)草藥產(chǎn)品的檢驗程序和可接受標(biāo)準(zhǔn)（第3修訂版草案）”。EMA的草藥及其產(chǎn)品的情況與我國中藥有相似之處，從起始物料到成品多為活性成分未知的復(fù)雜混合物。目前我國尚未制定關(guān)于中藥或中藥材（飲片）質(zhì)量標(biāo)準(zhǔn)相關(guān)指導(dǎo)原則。介紹該指南文件的主要內(nèi)容，并結(jié)合中藥質(zhì)量監(jiān)管情況進(jìn)行分析，以期EMA相關(guān)質(zhì)量標(biāo)準(zhǔn)制定的指導(dǎo)思路為制定中藥質(zhì)量標(biāo)準(zhǔn)提供參考。

The quality standards for herbs and their products differ from the specifications of the chemical drugs or biological products, so the European Medicines Agency (EMA) issued a "Guideline on specifications:test procedures and acceptance criteria for herbal substances, and herbal preparations for herbal and medicinal products/traditional herbal medicinal products (draft revision 3)" in 2018, The situation of EMA's herbs and their products is similar to that of traditional Chinese medicine. From the starting materials to the finished products, complex mixtures of active ingredients are unknown. At present, China has not yet formulated relevant guidelines for the quality standards of traditional Chinese medicine or Chinese herbal medicines (decoction pieces). Introduce the main contents of the guidance document and analyze the quality supervision of traditional Chinese medicine, with a view to guiding the development of EMA related to quality standards.