FDA对药品说明书中药物基因组学资料的要求

FDA's requirements for including pharmacogenomic information in durg labeling

美国食品药品监督管理局(FDA)于2013年1月发布了《临床药物基因组学指导原则:早期临床研究的上市前评价和对说明书的建议》,该指导原则旨在为制药工业界和其他从事新药研发的人在评价人体基因组的变异(尤其是DNA序列变异)如何影响药物的药动学(PK)、药效学(PD)、有效性或安全性方面提供帮助。介绍该指导原则的第五部分"药品说明书中包括的药物基因组学资料"内容,并列举了FDA公布的3个说明书实例,以期对我国药品说明书的撰写和监管工作的开展提供有益的借鉴,以便指导医生和患者合理用药。

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.