美国食品药品管理局(FDA)对药品说明书中老年用药信息的要求及启示  

FDA’s requirements for geriatric information in drug labeling and its enlightenment

作　　者：萧惠来 XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2021年第2期305-313,共9页Drug Evaluation Research

摘　　要：美国食品药品管理局(FDA)于2020年9月发布了供企业用"处方药和生物制品说明书中的老年用药信息"指导原则。该指导原则主要介绍对说明书中老年用药信息位置和内容的要求并给出描述的示例。内容极其详细、具体,便于操作。而我国尚无类似指导原则,详细介绍该指导原则,期望对我国相关指导原则的起草及其上位法规的修订有帮助,对药品说明书老年用药信息的撰写也有益。FDA issued Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry in September 2020. This guidance mainly introduces the requirements for the placement and content of geriatric information in labeling, and gives examples of description. The content is extremely detailed and specific, which is easy to operate. However, there is no similar guidance in China. This paper introduces the guidance in detail, hoping to be helpful to the drafting of relevant guidances and the revision of upper regulations in China, as well as the writing of geriatric information in drug labelings.

关 键 词：美国食品药品监督管理局 药品说明书 老年用药信息 “老年用药”项目 指导原则 

分 类 号：R951[医药卫生—药学]