美國(guó)食品藥品管理局（FDA）于2019年2月發(fā)布了"供企業(yè)用戒煙及相關(guān)適應(yīng)癥：開發(fā)尼古丁替代療法藥品的指導(dǎo)原則"（草案）。該指導(dǎo)原則介紹了FDA對(duì)尼古丁替代療法（NRT）藥品總體開發(fā)方案的建議，而我國(guó)目前尚無(wú)類似指導(dǎo)原則。介紹該指導(dǎo)原則的主要內(nèi)容，期待對(duì)我國(guó)這類藥的研發(fā)有益。

The FDA issued the Smoking Cessation and Related Indications:Developing Nicotine Replacement Therapy Drug Products Guidance for Industry (Draft) in February 2019. This guidance describes the FDA's recommendations regarding overall development programs to nicotine replacement therapy (NRT) drug products. There is no similar guidance in our country at present. This paper introduces the main contents of the guidance. It is expected to be beneficial to the research and development of this kind of drug products in China.