美國(guó)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(shuō)明書(shū)臨床藥理學(xué)項(xiàng)目——內(nèi)容和形式供企業(yè)用的指導(dǎo)原則”（正式版本）。該指導(dǎo)原則規(guī)定藥品說(shuō)明書(shū)臨床藥理學(xué)項(xiàng)目必須包括作用機(jī)制、藥效學(xué)和藥動(dòng)學(xué)3個(gè)小項(xiàng)；如果需要,可加設(shè)微生物學(xué)和藥物基因組學(xué)等小項(xiàng)并說(shuō)明了各小項(xiàng)應(yīng)包括的內(nèi)容,還闡述了該項(xiàng)目撰寫的一般原則和格式。介紹該指導(dǎo)原則的主要內(nèi)容,希望對(duì)我國(guó)處方藥說(shuō)明書(shū)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.