美國食品藥品監(jiān)督管理局（FDA）于2023年3月發(fā)布了《長效局部麻醉藥開發(fā)的供企業(yè)用的指導(dǎo)原則草案》。該指導(dǎo)原則針對(duì)長效局部麻醉藥新藥申請(qǐng)的不同適應(yīng)證和說明書的聲明，尤其是術(shù)后鎮(zhèn)痛，提出了對(duì)這類藥物開發(fā)和試驗(yàn)設(shè)計(jì)的詳細(xì)而具體的許多建議，包括一般臨床藥理學(xué)、人因工程學(xué)評(píng)價(jià)、試驗(yàn)設(shè)計(jì)、臨床有效性評(píng)價(jià)、臨床安全性評(píng)價(jià)和說明書的聲明等諸方面。而我國目前尚沒有類似的指導(dǎo)原則，詳細(xì)介紹FDA該指導(dǎo)原則的主要內(nèi)容，期望對(duì)我國這類藥物的開發(fā)研究及其監(jiān)管有所幫助。

The US Food and Drug Administration (FDA) released the Development of Local Anesthetic Drug Products with Prolonged Duration of Effect Draft Guidance for Industry in March 2023. This guidance provides detailed and specific recommendations for the development and trial design of new local anesthetic drug products with prolonged duration of effect for different indications and claims of labelings, especially for postoperative analgesia, including general clinical pharmacology, human factors engineering evaluation, trial design, clinical efficacy evaluation, clinical safety evaluation, and labeling claims. However, there is currently no similar guidance in China. This article provides a detailed introduction to the FDA's guidance, hoping to be helpful for the development, research, and regulation of such drugs in China.