歐洲藥品管理局（EMA）于2022年4月正式發(fā)布了歐洲藥品管理局草藥藥品委員會(huì)（Committee on Herbal Medicinal Products，HMPC）對(duì)草藥物質(zhì)丹參Salvia miltiorrhiza Bunge根或根莖的評(píng)估報(bào)告草案。其結(jié)論為根據(jù)現(xiàn)有數(shù)據(jù)，無(wú)法建立丹參的歐盟草藥專(zhuān)論。這一結(jié)論與傳統(tǒng)中醫(yī)藥學(xué)對(duì)丹參藥材的認(rèn)識(shí)和應(yīng)用，反差極大。重點(diǎn)介紹該報(bào)告的評(píng)論內(nèi)容，希望引起中國(guó)學(xué)術(shù)界和企業(yè)界的關(guān)注，并建議提供數(shù)據(jù)，包括文獻(xiàn)和試驗(yàn)資料，化解EMA的疑問(wèn)，縮小認(rèn)識(shí)的差距，達(dá)到某些共識(shí)，促進(jìn)丹參歐盟草藥專(zhuān)論的建立，便于今后丹參制品進(jìn)入歐洲市場(chǎng)。

European Medicines Agence (EMA) officially published the draft assessment report of the Committee on herbal medicinal products (HMPC) of the EMA on the herbal substance Salvia miltiorrhiza Bunge, radix et rhizoma in April 2022. The conclusion is that the EU herbal monograph on Salvia miltiorrhiza Bunge, radix et rhizoma can not be established according to the existing data. This conclusion is in great contrast with the understanding and application of Salvia miltiorrhiza in traditional Chinese medicine. This article focuses on the comments of the report, and hopping that it will attract the attention of the academic and business circles in China, and it is suggested to provide data, including literature and experimental data, to resolve the questions of EMA, narrow the understanding gap and reach some consensus,promote the establishment of European Union herbal monograph on Salvia miltiorrhiza, so as to facilitate the entry of traditional Chinese medicine Salvia miltiorrhiza products into Europe in the future.