歐洲藥品管理局（EMA）于2007年10月頒布了《歐白芷Angelica archangelic L.制劑中含有的呋喃香豆素相關(guān)的風(fēng)險(xiǎn)評(píng)估報(bào)告》，建議了關(guān)于草藥中呋喃香豆素的風(fēng)險(xiǎn)管理策略。歐盟當(dāng)局及其成員國(guó)往往要求申報(bào)者依據(jù)該評(píng)估報(bào)告對(duì)含當(dāng)歸的草藥制劑進(jìn)行安全性評(píng)估。介紹該評(píng)估報(bào)告的主要內(nèi)容，并勘誤了關(guān)于當(dāng)歸Angelica sinensis的2處錯(cuò)誤，闡述了筆者的觀點(diǎn)，期望對(duì)中國(guó)含當(dāng)歸的中成藥進(jìn)入歐洲市場(chǎng)有所啟示。

The European Medicines Agency released "Reflection Paper on the Risk Associated with Furocoumarins Contained in Preparations of Angelica archangelica L." in October 2007, which proposed risk-management strategy for furocoumarins contained in herbal preparations. The European Union or Member States authorities often require applicants to conduct safety assessments of relevant herbal preparations containing Angelica based on the reflection paper. This paper introduces the main contents of the reflection paper, corrects two errors about Angelica sinensis, states the author's opinions in conclusion and discussion, and is expected to give some enlightenment for Chinese herbal preparations containing Angelica to enter the European market.

R951

科技部“重大新藥創(chuàng)制”重大專項(xiàng)資助項(xiàng)目（2018ZX09303024）