仿制药生物等效性研究国际协调的现状  

Current status of international coordination on bioequivalence of generic drug

作　　者：李逸云 袁利佳 LI Yi-yun;YUAN Li-jia(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：《中国临床药理学杂志》2024年第23期3516-3520,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：本文介绍了仿制药注册技术要求的国际协调情况及重大改进。各国生物等效性指导原则存在差异,为了促进仿制药国际互认,各国监管机构通过国际协调组织平台推进技术互认,在空腹及餐后生物等效性试验方面取得了重大进展,将在保证高质量的前提下,进一步降低仿制药研发成本。自我国国家药品监督管理局加入国际人用药品注册技术协调会(ICH)以来,国家药品监督管理局药品审评中心积极参与了仿制药注册技术标准的协调工作,随着我国仿制药技术要求与国际接轨,我国仿制药质量标准体系在ICH相关指导原则指导下,得到较大的发展。This paper provided an overview of the significant progress made by international coordinating organizations in the requirements for generic drug registration.There are differences in the guidelines for bioequivalence among different countries.In order to promote international mutual recognition of generic drugs,regulatory agencies in various countries and regions coordinated to technical mutual recognition through international coordination organization platforms,and made significant progress in fast and fed bioequivalence study,which will further reduce the cost of generic drug development while ensuring high quality of that.Since China’s National Medical Products Administration joined The International Council for Harmonization(ICH),the Drug Evaluation Center has been involved in the coordination of technical standards for generic drug registration.With the technical requirements of Chinese generic drugs in line with international standards,the quality standard system of Chinese generic drugs has been greatly developed under the guidance of relevant ICH guiding principles.

关 键 词：生物等效性 空腹试验 餐后试验 国际协调 

分 类 号：R97[医药卫生—药品]