美國食品藥品監(jiān)督管理局（FDA）于2013年2月發(fā)布了《人用處方藥和生物制品說明書兒科資料指導(dǎo)原則（草案）》，該指導(dǎo)原則詳細規(guī)定了兒科資料在處方藥說明書中的合適位置以及內(nèi)容要求，以指導(dǎo)兒科患者的合理用藥。介紹該指導(dǎo)原則的主要內(nèi)容，包括FDA對處方藥說明書兒科資料要求的主要法規(guī)依據(jù)、兒科年齡分段、決策的兒科資料分類等背景資料，以及兒科資料在說明書中具體要求，以期對我國處方藥說明書的撰寫和監(jiān)管工作的開展提供有益的借鑒，以便指導(dǎo)醫(yī)生和患者合理用藥。

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 The draft guidance provides the recommendations on placement and content of pediatric data in human prescription drug and biological products specifications, which aims at giving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.