歐洲藥品局（EMA）于2018年11月發(fā)布了"人用藥品輔料聚山梨酯的包裝說(shuō)明書資料（草案）"文件，詳細(xì)評(píng)價(jià)了聚山梨酯的安全性。介紹該文件中有關(guān)藥品說(shuō)明書中輔料聚山梨酯安全性資料撰寫的新要求，期望我國(guó)相關(guān)的藥品生產(chǎn)廠家借鑒EMA的做法，在含有輔料聚山梨酯的藥品說(shuō)明書中提供聚山梨酯的安全性信息，確保用藥者的安全。

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.

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