我国鼓励仿制药品目录清单(第一批)品种特征及口服固体制剂生物等效性研究要求分析

Analysis of China encourage generic drug catalogue(first batch) characteristic and oral solid preparation bioequivalence requirement

为及时满足国内临床用药需求,2019年10月,国家卫生健康委员会正式发布《关于印发第一批鼓励仿制药品目录的通知》。检索并整理了全部纳入品种的适应症、批准文号数量、临床试验登记等信息,结合美国食品药品管理局(FDA)发布的生物等效性研究个药指南,对目录中涉及的固体口服制剂生物等效性研究要求进行梳理,并结合涉及品种的相关特征与生物等效性研究要求进行分析,以期为国内研究机构及原研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, National health commission released "Encourage generic drug catalogue(the first batch)". In this paper, we sorted out the indications, the number of approval and the registration of clinical trials in this catalogue. The bioequivalence requirements of the solid oral preparations in this catalogue by FDA were summarized and several analysis were put forward based on this characteristics. aimed to provide scientific reference for research and development on this kind of drugs.