FDA对药品说明书适应症项目的要求

FDA requirements for indications and usage section of drug labeling

美国食品药品管理局(FDA)于2018年7月发布了"人用处方药和生物制品说明书的适应症和应用项目——内容和格式供企业用指导原则(草案)"。该指导原则指出适应症和应用项目一般由适应症和使用限制两部分组成,并详细介绍了该项目应包括的内容和格式,同时告诫不应出现的内容和格式。介绍该指导原则的主要内容,期望对我国药品说明书适应症项目的撰写和监管有益。

FDA issued Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format Guidance for Industry(Draft) in July, 2018. The guidance suggested that indications and usage section generally consist of indications and limitations of use. The guidance detailed the content and format which should be included in the section, and cautioned against the content and format that should not occur. This paper introduces the guidance in detail and expects to be beneficial to the writing and supervision of the indication section of drug labeling in China.