FDA对处方药说明书[患者须知]的要求

Requirements by FDA for patient counseling information section of prescription drug labeling

美国食品和药品管理局(FDA)于2013年9月发布了"人用处方药和生物制品说明书[患者须知]部分内容和形式(草案)"的指导原则。介绍其中对[患者须知]内容和形式的要求并说明其产生的背景,特别是法律依据。目前我国处方药说明书专业性很强,没有设置[患者须知]项目,也无针对患者的说明书。综述了FDA该指导原则的主要内容,期望为打开我国说明书直面患者的大门起到一定的积极作用。

FDA issued ＂Guidance for Industry Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products -- Content and Format （Draft）＂ in September of 2013. This paper introduces the requirements for the content and format of patient counseling information section and explains its background, especially the legal basis. In our country the prescription drug labeling is very professional and does not include patient counseling information section. There is also no patient labeling. This paper introduces the main contents of the guidance of FDA, It is expected to play an active role in opening the door of our labeling directly toward patients.