《药物临床依赖性研究技术指导原则(试行)》起草背景及要点内容  

Background and key elements of Guidance of Clinical Drug Dependence Research

作　　者：张豪 王朝云 李强 丛端端 孙艳喆 王丽卿 耿莹 ZHANG Hao;WANG Zhao-yun;LI Qiang;CONG Duan-duan;SUN Yan-zhe;WANG Li-qing;GENG Ying(Centre 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：《中国临床药理学杂志》2024年第23期3509-3515,共7页The Chinese Journal of Clinical Pharmacology

摘　　要：目前,我国中枢神经系统(CNS)领域药物研发进展迅速,在CNS药物研发的过程中需要及早对其可能存在的药物滥用潜力进行监测,通过对药学、非临床和临床证据的综合评估,评价其药物依赖性情况。欧洲药品管理局(EMA)及美国食品药品监督管理局(FDA)均已出台了相关指导原则用以管理有滥用潜力的药物,我国国家药品监督管理局也发布了《药物非临床依赖性研究技术指导原则》。因此,为指导CNS药物研发,监测相关药物滥用潜力,确保患者用药安全,指导临床合理用药,国家药品监督管理局于2022-09-28发布了《药物临床依赖性研究技术指导原则(试行)》。临床依赖性评估是滥用潜力药物安全性评价的重要内容,由于具有特殊研究目的和评价要求,其研究过程及数据来源贯穿于临床研究全过程,通过对临床研究全程产生的相关数据的综合分析,得到关于药物临床依赖性情况的证据。本文将介绍该项指导原则的起草背景及要点内容。At present,the research and development of drugs in the central nervous system(CNS)field in China is progressing rapidly.In the process of CNS drug development,it is necessary to monitor the potential drug abuse as early as possible,and evaluate the drug dependence through comprehensive evaluation of pharmaceutical,non clinical and clinical evidence.At present,both European Medicines Agency(EMA)and Food and Drug Administration(FDA)have issued relevant guidelines to manage drugs with potential abuse,and China’s National Medical Products Administration has also released the guidance of non-clinical drug dependence research.Therefore,in order to guide the development of CNS drugs,monitor the potential drug abuse,ensure patient medication safety,and guide clinical rational medication,On 28 September 2022,guidance of clinical drug dependence research was published.Clinical dependency assessment is an important part of the safety evaluation of drugs with abuse potential.Due to its special research purpose and evaluation requirements,its research process and data sources run through the entire clinical research.Analysis of relevant data generated throughout the clinical research process,evidence about drug clinical dependency is obtained.This article will introduce the background and key elements of this guidance.

关 键 词：中枢神经系统药物 药物临床依赖性 滥用潜力药物 指导原则 

分 类 号：R971[医药卫生—药品]