血液制品病毒安全性药学审评考虑  

Considerations on pharmaceutical review for viral safety of blood products

作　　者：贾东晨 于鹏丽 吴舟一 韦薇 JIA Dong-chen;YU Peng-li;WU Zhou-yi;WEI Wei(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,北京100122

出　　处：《中国新药杂志》2023年第2期168-173,共6页Chinese Journal of New Drugs

摘　　要：血液制品由健康人血浆分离制备,适应证广泛,在一些重大疾病的预防与治疗方面疗效显著。但因其来源的特殊性,导致血液制品的病毒安全性一致被各国监管机构高度关注。本文将结合审评实践,从原料血浆、病毒去除/灭活工艺、相关法规要求及审评考量等方面,探讨血液制品审评中病毒安全性相关问题,以期为此类产品的研发生产提供参考。Blood products are manufactured by separation of plasma from healthy donors,which have a wide range of indications and play a critical role in the prevention and treatment of certain major diseases.However,because of the uniqueness of their source,the viral safety of blood products is always highly concerned by various national regulatory authorities.This manuscript discussed viral safety-related issues of blood products in combination with technical review practice,from aspects like source plasma,virus removal/inactivation processes,regulation requirements and considerations in technical review,etc.,in order to provide references for future research and development.

关 键 词：血液制品 病毒安全性 原料血浆 病毒去除/灭活验证 

分 类 号：R95[医药卫生—药学]