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(xué)——考慮的因素、內(nèi)容和形式供企業(yè)用的指導(dǎo)原則(草案)”,對(duì)藥品說明書撰寫的一般原則、作用機(jī)制、藥效學(xué)和藥動(dòng)學(xué)的具體內(nèi)容以及表達(dá)方式都做了詳盡的說明。介紹該指導(dǎo)原則的主要內(nèi)容,希望對(duì)改進(jìn)我國藥品說明書相應(yīng)內(nèi)容的撰寫和修訂有幫助,并有益于更新完善我國相應(yīng)法規(guī)和創(chuàng)建相應(yīng)的指導(dǎo)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FDA issued the draft guidance for industry Pharmacology Labeling for Human Prescription Drug and Biological Products— Considerations, Content, and Format in August 2014.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.