美國(guó)食品藥品監(jiān)督管理局（FDA）于2013年1月發(fā)布了《臨床藥物基因組學(xué)指導(dǎo)原則：早期臨床研究的上市前評(píng)價(jià)和對(duì)說(shuō)明書(shū)的建議》，該指導(dǎo)原則旨在為制藥工業(yè)界和其他從事新藥研發(fā)的人在評(píng)價(jià)人體基因組的變異（尤其是DNA序列變異）如何影響藥物的藥動(dòng)學(xué)（PK）、藥效學(xué)（PD）、有效性或安全性方面提供幫助。介紹該指導(dǎo)原則的第五部分“藥品說(shuō)明書(shū)中包括的藥物基因組學(xué)資料”內(nèi)容，并列舉了FDA公布的3個(gè)說(shuō)明書(shū)實(shí)例，以期對(duì)我國(guó)藥品說(shuō)明書(shū)的撰寫(xiě)和監(jiān)管工作的開(kāi)展提供有益的借鑒，以便指導(dǎo)醫(yī)生和患者合理用藥。

US Food and Drug Administration (FDA) issued Guidance for Industry Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling on January in 2013. The guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect the pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety of a drug. This artical introduces Part V of the guidance "Including Pharmacogenomic Information in Labeling", and gives three labeling examples approved by FDA, expecting to provide some useful suggests for writing and supervision of drug labeling in China.