美国FDA致幻药临床研究考虑要点的行业指导原则草案介绍  

Introduction to FDA's Psychedelic Drugs:Considerations for Clinical Investigations Guidance for Industry

作　　者：萧惠来 Xiao Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国药事》2024年第8期969-974,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:促进我国对致幻药精神心理疾病治疗应用的开发、研究和监管。方法:在美国食品药品管理局(FDA)网站,查寻新近发布的相关指导原则并详细而具体地介绍该指导原则。结果与结论:展示了FDA于2023年6月发布的“致幻药临床研究考虑要点的行业指导原则草案”的具体内容,为开发用于治疗精神心理疾病(例如精神障碍、物质使用障碍)的致幻药提出了一些临床研究的一般考虑因素,以确保符合伦理要求以及试验完整性和结果可靠性。指导原则按专业领域分别讨论了致幻药与临床研究相关的化学、生产和控制;非临床试验;临床药理学;滥用可能性评估和临床试验方面面临的特殊问题。该指导原则对我国开展这方面的工作具有重要参考价值。Objective:To promote the development,research,and regulation of psychedelic drugs for the treatment of psychiatric and psychological disorders in China.Methods:The newly issued relevent guidances were searched on the website of US Food and Drug Administration(FDA),and a detailed and specific introduction to them was provided.Results and Conclusion:The specific content of the FDA's Psychedelic Drugs:Considerations for Clinical Investigations Draft Guidance for Industry issued in June 2023 was presented,which proposes some general considerations for the development of psychedelic drugs for the treatment of psychiatric and psychological disorders(e.g.,psychiatric disorders,substance use disorders)in clinical researches to ensure compliance with ethical requirements,trial integrity,and reliability of results.The guidance discussed the special issues faced in the following professional fields related to psychedelic drugs and clinical research separately:chemistry,manufacturing,and controls;nonclinical trials;cinical pharmacology;abuse potential assessment and clinical trials.This guidance has important reference value for China to carry out work in this area.

关 键 词：美国食品药品管理局 致幻药 精神心理疾病 临床研究 指导原则 

分 类 号：R95[医药卫生—药学]