FDA对治疗性蛋白质产品与参照药可互换性研究的要求  

FDA requirements for study on interchangeability of therapeutic protein product with reference product

作　　者：萧惠来 XIAO Huilai(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》2020年第7期1207-1215,共9页Drug Evaluation Research

摘　　要：美国食品药品管理局(FDA)于2019年5月发布了“供企业用证明与参照药可互换性考虑的问题的指导原则”(正式版本)。该指导原则介绍了FDA对治疗性蛋白质产品与参照药可互换性研究的原则要求和具体研究数据和信息的要求。而中国目前尚无类似指导原则。详细介绍该指导原则主要内容,期望对我国这方面的研究和监管能走在世界前列有所帮助。FDA issued the Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry(final)in May 2019.This guidance introduces the FDA's requirements on the principles and the specific research data and information of interchangeability between therapeutic protein products and reference products.There is no similar guidance at present in China.This paper introduces the guidance in detail,hoping that it will be helpful for our research and supervision in this field to lead the world.

关 键 词：美国食品药品监督管理局 治疗性蛋白质产品 参照药 可互换性 指导原则 

分 类 号：R951[医药卫生—药学]