[关键词]
[摘要]
欧盟委员会于2018年3月发布了"人用药品标签和包装说明书中的辅料"指导原则及其附件。该文件介绍了辅料的定义、用语,并在其附件中提供了辅料表,用以说明必须出现在包装说明书上的信息。期望我国生产厂家借鉴欧盟的做法,在含有辅料表中辅料的说明书中提供安全性信息,确保用药者的安全。
[Key word]
[Abstract]
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.
[中图分类号]
[基金项目]