FDA的《长效局部麻醉药开发供企业用指导原则草案》介绍  

Introduction to FDA's Development of Local Anesthetic Drug Products with Prolonged Duration of Effect Draft Guidance for Industry

作　　者：萧惠来 XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2023年第6期1168-1174,共7页Drug Evaluation Research

摘　　要：美国食品药品监督管理局(FDA)于2023年3月发布了《长效局部麻醉药开发的供企业用的指导原则草案》。该指导原则针对长效局部麻醉药新药申请的不同适应证和说明书的声明,尤其是术后镇痛,提出了对这类药物开发和试验设计的详细而具体的许多建议,包括一般临床药理学、人因工程学评价、试验设计、临床有效性评价、临床安全性评价和说明书的声明等诸方面。而我国目前尚没有类似的指导原则,详细介绍FDA该指导原则的主要内容,期望对我国这类药物的开发研究及其监管有所帮助。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Drug Administration(FDA)released the Development of Local Anesthetic Drug Products with Prolonged Duration of Effect Draft Guidance for Industry in March 2023.This guidance provides detailed and specific recommendations for the development and trial design of new local anesthetic drug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.

关 键 词：美国食品药品监督管理局(FDA) 新药申请 长效局部麻醉药 药物开发 试验设计 指导原则 

分 类 号：R951[医药卫生—药学]