美國食品藥品管理局（FDA）于2016年12月發(fā)布了“人用處方藥和生物制品說明書臨床藥理學項目——內(nèi)容和形式供企業(yè)用的指導原則”（正式版本）。該指導原則規(guī)定藥品說明書臨床藥理學項目必須包括作用機制、藥效學和藥動學3個小項；如果需要,可加設(shè)微生物學和藥物基因組學等小項并說明了各小項應(yīng)包括的內(nèi)容,還闡述了該項目撰寫的一般原則和格式。介紹該指導原則的主要內(nèi)容,希望對我國處方藥說明書的撰寫和監(jiān)管有所幫助。

FDA issued the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format Guidance for Industry (final guidance)in December 2016. The Guidance stipulated that clinical pharmacology section must contain three subsections-mechanism of action, pharmacodynamics, and pharmacokinetics; If necessary, it can be added to microbiology and pharmacogenomics subsections etc., as well as explained that the contents of each subsection should be included, also discussed the writing general principles and the format of the section. This paper introduces the main contents of the guidance, with the hope of helping writing and supervision on our country labeling.