阿片类处方药滥用在全球已成为严重的公共卫生问题,防滥用阿片类制剂可不同程度地阻止其滥用.FDA为鼓励、支持和加速研发可遏制滥用的阿片类产品,于2013年公布了"防滥用的阿片类药物——评价和说明书"指导原则(草案).介绍该指导原则的主要内容,包括上市前的实验室破坏和提取研究、药动学研究、临床滥用可能性研究和上市后研究,希望对我国这方面的研究和审评有帮助.

Abuse of opioids has become a serious public health problem in the world, and abuse deterrence of opioids could prevent abuse to varying degrees. To encourage, support, and facilitate the research and development on abuse deterrence of opioids, FDA announced the "Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling (draft)" in 2013. This article introduces the main content of the guidance, including premarketing studies of laboratory manipulation and extraction studies, pharmacokinetic studies and clinical abuse potential studies as well as post-marketing studies. It is expected to be helpful for the research and review on this field in China.