[关键词]
[摘要]
欧洲药品局(EMA)于2018年11月发布了"人用药品辅料聚山梨酯的包装说明书资料(草案)"文件,详细评价了聚山梨酯的安全性。介绍该文件中有关药品说明书中辅料聚山梨酯安全性资料撰写的新要求,期望我国相关的药品生产厂家借鉴EMA的做法,在含有辅料聚山梨酯的药品说明书中提供聚山梨酯的安全性信息,确保用药者的安全。
[Key word]
[Abstract]
EMA released the document "Information for the package leaflet regarding polysorbates used as excipients in medicinal products for human use (Draft)" in November 2018. The safety of polysorbates was evaluated in detail in this document. This paper introduces the new requirements for safety data of polysorbates used as excipients in the package leaflet. It is hoped that Chinese manufacturers will learn from the practice of the European Union and provide safety information of polysorbates used as excipients in the package leaflet to ensure the safety of drug users.
[中图分类号]
R954
[基金项目]