FDA对处方药说明书临床药理学项目的要求

FDA's requirements for clinical pharmacology section of prescription drug labeling

美国食品药品管理局(FDA)于2016年12月发布了"人用处方药和生物制品说明书临床药理学项目——内容和形式供企业用的指导原则"(正式版本)。该指导原则规定药品说明书临床药理学项目必须包括作用机制、药效学和药动学3个小项;如果需要,可加设微生物学和药物基因组学等小项并说明了各小项应包括的内容,还阐述了该项目撰写的一般原则和格式。介绍该指导原则的主要内容,希望对我国处方药说明书的撰写和监管有所帮助。

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—echanism 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.