张明,萧惠来.EMA对说明书中辅料乳糖和环糊精安全性资料的最新要求[J].药物评价研究,2019,42(8):1498-1502
EMA对说明书中辅料乳糖和环糊精安全性资料的最新要求
Latest requirements of EMA for safety data of lactose and cyclodextrins used as excipients in package leaflet
投稿时间:2019-03-23  
DOI:10.7501/j.issn.1674-6376.2019.08.002
中文关键词:  欧洲药品局;乳糖;环糊精;药用辅料;安全性资料;药品说明书
英文关键词:EMA;lactose;cyclodextrins;pharmaceutical excipient;clinical safety data;package leaflet
基金项目:
作者单位E-mail
张明 国家药品监督管理局 药品审评中心, 北京 100022  
萧惠来 国家药品监督管理局 药品审评中心, 北京 100022 penglai8051@aliyun.com 
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中文摘要:
      欧洲药品局(EMA)于2017年10月发布了"有关人用药品辅料环糊精的问答"文件,该文件回答了环糊精作为人用药品辅料使用中的安全性等问题。2018年11月EMA又发布了"人用药品辅料乳糖的包装说明书资料(草案)"文件,详细评价了乳糖的安全性。介绍上述2个文件中有关说明书中新的辅料乳糖和环糊精安全性资料撰写要求的内容,期望我国生产厂家借鉴欧盟的做法,在含有辅料乳糖和环糊精的说明书中提供乳糖和环糊精的安全性信息,确保用药者的安全。
英文摘要:
      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.
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