美國食品藥品管理局(FDA)于2014年8月發(fā)布了“人用處方藥和生物制品說明書臨床藥理學——考慮的因素、內(nèi)容和形式供企業(yè)用的指導原則(草案)”,對藥品說明書撰寫的一般原則、作用機制、藥效學和藥動學的具體內(nèi)容以及表達方式都做了詳盡的說明。介紹該指導原則的主要內(nèi)容,希望對改進我國藥品說明書相應內(nèi)容的撰寫和修訂有幫助,并有益于更新完善我國相應法規(guī)和創(chuàng)建相應的指導原則。

FDA issued the draft guidance for industry Pharmacology Labeling for Human Prescription Drug and Biological Products— Considerations, Content, and Format in August 2014.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.