摘要
美国食品药品管理局(Food and Drug Administration,FDA)于2022年2月发布了“用于急性疼痛的非阿片类镇痛药的开发供企业用的指导原则草案”,旨在帮助申请人开发用于治疗持续30 d的急性疼痛的阿片类药物替代品,促进这类药物的发展,减少阿片类药物的使用,对抗阿片类药物的误用、滥用和成瘾。该指导原则阐述了FDA目前对下列3方面的具体看法:用于急性疼痛的非阿片类镇痛药的临床试验方案、其说明书中关于消除或减少阿片类药物使用的描述以及这类药物的加快审批程序。重点是前两者,尤其是临床试验方案。而中国目前还没有类似的指导原则,详细介绍该指导原则,期望对中国这类药物的临床研究及其监管有所帮助。
FDA issued the Development of Non-Opioid Analgesics for Acute Pain Draft Guidance for Industry in February 2022,which aims to help sponsors develop opioid alternatives for the treatment of acute pain lasting for 30 days, promote the development of such drugs, reduce the use of opioids and combat the misuse, abuse and addiction of opioids. The guidance set forth FDA’s current specific thinking about the following three aspects: the clinical trial program of non-opioid analgesics for acute pain, the claims of eliminating or reducing the use of opioids in its labeling, and the expedited review programs of such drugs. The focus is on the first two, especially the clinical trial program. At present, there is no similar guidance in China. This paper introduces the guidance in detail, and looks forward to being helpful to the clinical research and supervision of this kind of drugs in China.
作者
萧惠来
XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2022年第5期822-827,共6页
Drug Evaluation Research
