FDA新版处方药说明书[临床药理学]撰写指导原则

Guidance writing principle of new version of FDA on clinical pharmacology section in labeling for prescription drug

美国食品药品管理局(FDA)于2014年8月发布了"人用处方药和生物制品说明书临床药理学——考虑的因素、内容和形式供企业用的指导原则(草案)",对药品说明书撰写的一般原则、作用机制、药效学和药动学的具体内容以及表达方式都做了详尽的说明。介绍该指导原则的主要内容,希望对改进我国药品说明书相应内容的撰写和修订有帮助,并有益于更新完善我国相应法规和创建相应的指导原则。

FDA issued the draft guidance for industry Pharmacology Labeling for Human Prescription Drug and Biological Products-- Considerations, Content, and Format in August 2014. The general principles of writing and specific content and expression methods of action mechanism, pharmacodynamics, and pharmacokinetics are described in detail. This article introduces the main contents. It is hoped to help improve writing and revision of our corresponding Labeling contents, also update and perfect the corresponding regulations and create the corresponding guidance in our country.