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)用的指導原則草案》。該指導原則針對長效局部麻醉藥新藥申請的不同適應證和說明書的聲明，尤其是術(shù)后鎮(zhèn)痛，提出了對這類藥物開發(fā)和試驗設計的詳細而具體的許多建議，包括一般臨床藥理學、人因工程學評價、試驗設計、臨床有效性評價、臨床安全性評價和說明書的聲明等諸方面。而我國目前尚沒有類似的指導原則，詳細介紹FDA該指導原則的主要內(nèi)容，期望對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Drug Administration (FDA) released the Development of Local Anesthetic Drug Products with Prolonged Duration of Effect Draft Guidance for Industry in March 2023.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.