中国鼓励仿制药品目录(第二批)品种特征及生物等效性研究要求  

China encourage generic drug catalogue (second batch) characteristic and bioequivalence requirement

作　　者：韩鸿璨 刘冬 王骏 HAN Hongcan;LIU Dong;WANG Jun(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1期1-7,共7页Drug Evaluation Research

摘　　要：为及时满足国内临床用药需求,国家卫生健康委员会分别于2019年10月、2021年2月发布2批《鼓励仿制药品目录清单》。检索并整理了《鼓励仿制药品目录(第二批)》纳入品种的适应证、批准文号数量、临床试验登记等信息,结合美国食品药品监督管理局(FDA)发布的生物等效性研究个药指南,对目录中涉及的相关品种生物等效性研究要求进行梳理,结合品种特征与生物等效性研究要求进行了初步分析,以期为国内研究机构及企业开展相关研究提供科学依据与参考。To meet the domestic demand for clinical timely, in October 2019 and February 2021, National Health Commission released two batches "Encourage generic drug catalogue". It was sorted out the indications, the number of approval and the registration of clinical trials in "Encourage generic drug catalogue(the second batch)" in this paper. The bioequivalence requirements of preparations in this catalogue by US Food and Drug Administration(FDA) were summarized and several analyses were put forward based on this characteristics, aimed to provide scientific reference for research and development on this kind of drugs.

关 键 词：仿制药品 鼓励仿制药品目录 品种特征 生物等效性 批准文号 

分 类 号：R915[医药卫生—微生物与生化药学]