歐盟（European Union，EU）于2016年7月發(fā)布了《在歐盟草藥專論編寫中評估公認(rèn)的和傳統(tǒng)的草藥產(chǎn)品臨床安全性和有效性的指導(dǎo)原則（第一次修訂版）》。其中最值得注意的是，草藥產(chǎn)品申請注冊時可用文獻(xiàn)資料替代試驗資料，并且可根據(jù)文獻(xiàn)資料科學(xué)性不同，獲準(zhǔn)不同的適應(yīng)證。介紹該指導(dǎo)原則的主要內(nèi)容，期望對我國的中藥和植物藥研究及其監(jiān)管有所幫助。

The European Union released Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products rev. 1 in July 2016. It is noteworthy in the guideline that the test data can be replaced by the literature when the herbal medicine products are applied for registration and according to the scientific strength of the literature, different indications can be approved. This paper introduces the main contents of the guideline and is expected to inspire the research and supervision of Chinese materia medica and phytomedicine in China.