EMA于2017年8月發(fā)布了"公認(rèn)和傳統(tǒng)草藥產(chǎn)品申請上市許可或注冊的非臨床文件的指導(dǎo)原則（草案）"。該指導(dǎo)原則指出傳統(tǒng)和公認(rèn)的草藥物質(zhì)或制劑，在獲得人體充分而詳實(shí)經(jīng)驗(yàn)的情況下，單次給藥和重復(fù)給藥毒性、毒代動(dòng)力學(xué)研究、免疫毒性以及局部耐受性試驗(yàn)是不必要的；而其生殖毒性、遺傳毒性和致癌性，如果發(fā)表的文獻(xiàn)不能用或不足，附加非臨床試驗(yàn)是必要的。詳細(xì)介紹該指導(dǎo)原則主要內(nèi)容，以期對擬在歐盟上市的中草藥產(chǎn)品有所幫助，也對我國草藥監(jiān)管有所啟發(fā)。

EMA in August 2017 issued "guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products (Draft)", which pointed that it is no necessary to carry out the test of single dose and repeated dose toxicity, toxicokinetic studies, immunotoxicity as well as local tolerance of traditional and well-established herbal substances or preparations under the condition that sufficient and well-documented experience is available in humans. However, additional non-clinical testing would be necessary, if the content of the toxicity of reproduction, genotoxicity and carcinogenicity in the published literature is not available or insufficient. This article describes the guideline in detail and is expected to be a direct help to the traditional Chinese medicines and herbal medicines that are intended to be marketed in the European Union, as well as to have inspiration on the supervision.