歐洲藥品局（EMA）于2017年10月發(fā)布了"有關(guān)人用藥品輔料環(huán)糊精的問(wèn)答"文件，該文件回答了環(huán)糊精作為人用藥品輔料使用中的安全性等問(wèn)題。2018年11月EMA又發(fā)布了"人用藥品輔料乳糖的包裝說(shuō)明書資料（草案）"文件，詳細(xì)評(píng)價(jià)了乳糖的安全性。介紹上述2個(gè)文件中有關(guān)說(shuō)明書中新的輔料乳糖和環(huán)糊精安全性資料撰寫要求的內(nèi)容，期望我國(guó)生產(chǎn)廠家借鑒歐盟的做法，在含有輔料乳糖和環(huán)糊精的說(shuō)明書中提供乳糖和環(huán)糊精的安全性信息，確保用藥者的安全。

EMA released the document "Questions and answers on cyclodextrins used as excipients in medicinal products for human use " in October 2017. EMA released the document " Information for the package leaflet regarding lactose used as an excipient in medicinal products for human use (Draft)" in November 2018. The safety of lactose was evaluated in detail in this document. The document answered questions about the safety of cyclodextrin as an excipients in medicinal products for human use. This paper introduces the new requirements for safety data of lactose and cyclodextrins 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 lactose and cyclodextrins used as excipients in the package leaflet to ensure the safety of drug users.