美國(guó)食品藥品管理局（FDA）于2018年7月發(fā)布了“人用處方藥和生物制品說(shuō)明書(shū)的適應(yīng)癥和應(yīng)用項(xiàng)目——內(nèi)容和格式供企業(yè)用指導(dǎo)原則（草案）”。該指導(dǎo)原則指出適應(yīng)癥和應(yīng)用項(xiàng)目一般由適應(yīng)癥和使用限制兩部分組成，并詳細(xì)介紹了該項(xiàng)目應(yīng)包括的內(nèi)容和格式，同時(shí)告誡不應(yīng)出現(xiàn)的內(nèi)容和格式。介紹該指導(dǎo)原則的主要內(nèi)容，期望對(duì)我國(guó)藥品說(shuō)明書(shū)適應(yīng)癥項(xiàng)目的撰寫(xiě)和監(jiān)管有益。

qFDA 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.