美国食品药品监督管理局（FDA）于2013年2月发布了《人用处方药和生物制品说明书儿科资料指导原则（草案）》，该指导原则详细规定了儿科资料在处方药说明书中的合适位置以及内容要求，以指导儿科患者的合理用药。介绍该指导原则的主要内容，包括FDA对处方药说明书儿科资料要求的主要法规依据、儿科年龄分段、决策的儿科资料分类等背景资料，以及儿科资料在说明书中具体要求，以期对我国处方药说明书的撰写和监管工作的开展提供有益的借鉴，以便指导医生和患者合理用药。

US Food and Drug Administration (FDA) issued “Guidance for Industry and Review Staff Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling (Draft)” on February 2013. The draft guidance provides the recommendations on placement and content of pediatric data in human prescription drug and biological products specifications, which aims at giving the guidance for the appropriate use of drugs in treating pediatric patients. This article introduces its main content, including the background of FDA main regulatory foundation on the requirement of pediatric data in human prescription drugs specifications, pediatric age categories, and categorise of pediatric data for decision making, as well as the details of requirement on pediatric data in specifications, expecting to provide the useful guidance for writing and supervision of drug specifications in China.