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的風險評估報告》，建議了關于草藥中呋喃香豆素的風險管理策略。歐盟當局及其成員國往往要求申報者依據(jù)該評估報告對含當歸的草藥制劑進行安全性評估。介紹該評估報告的主要內(nèi)容，并勘誤了關于當歸Angelica sinensis的2處錯誤，闡述了筆者的觀點，期望對中國含當歸的中成藥進入歐洲市場有所啟示。

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.

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