歐盟委員會(huì)于2018年3月發(fā)布了"人用藥品標(biāo)簽和包裝說(shuō)明書(shū)中的輔料"指導(dǎo)原則及其附件。該文件介紹了輔料的定義、用語(yǔ)，并在其附件中提供了輔料表，用以說(shuō)明必須出現(xiàn)在包裝說(shuō)明書(shū)上的信息。期望我國(guó)生產(chǎn)廠(chǎng)家借鑒歐盟的做法，在含有輔料表中輔料的說(shuō)明書(shū)中提供安全性信息，確保用藥者的安全。

European Commission released the guidelines "Excipients in the labeling and package leaflet of medicinal products for human use" and annex in March 2018.The document describes the definition of excipients, the nomenclature, and provides a list of excipients which should be stated on the label and outlines the information for those which must appear on the package leaflet in its annexes. It is hoped that Chinese manufacturers will learn from the practice of the European Union and provide safety information of excipients in the package leaflet to ensure the safety of drug users.