FDA患者用“使用说明书(IFU)”内容和格式指导原则介绍

Introduction of FDA instructions for use-patient labeling-content and format guidance

美国食品药品监督管理局(FDA)于2019年7月发布了"使用说明书(IFU)——人用处方药和生物制品以及药品-器械和生物制品-器械组合产品的患者用说明书——内容和格式供企业用指导原则(草案)",该指导原则对IFU的内容和格式提出了建议。提供专为患者阅读的说明书是国际惯例,IFU只是这类说明书的一种,而中国目前尚无这种说明书。详细介绍该指导原则的主要内容,期待通俗易懂的患者用说明书早日在中国问世。

The FDA issued the Instructions for Use - Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products - Content and Format Guidance for Industry(Draft) in July 2019. The guidance provided suggestions on the content and format of the Instructions for Use(IFU). It is an international practice to provide specific Patient Labeling. IFU is just one of these Labelings. At present, there is no such Labelings in our country. This paper introduces the guidance in detail and calls for the publication of easy-to-understand patient Labelings in China.