基于疫苗管理及技术特点浅析疫苗上市后变更注册的几点特殊考虑

Several special considerations on the registration of post-approval changes for vaccines based on lifecycle management

上市后变更作为生物制品全生命周期管理的重要环节之一,可能给生物制品质量带来潜在影响。预防用疫苗在法规要求、产品特点、生产质控等方面与其他生物制品有所不同,因此在开展上市后变更研究和注册时存在特殊考虑。本文就疫苗产品与其他生物制品开展上市后变更进行了技术要求对比分析,提炼了疫苗上市后变更研究的若干特别考虑因素,以期对疫苗持有人做好上市后变更研究有所助益。

As a critical part of the lifecycle management of biological products,post-approval changes may bring potential impact on the quality of biological products.Compared with other therapeutic products,prophylactic vaccines show different emphasis on regulatory requirements,product characteristics,manufacturing quality control,etc.so there are special considerations on the research and registration of post-approval changes.Aiming to help vaccine applicants increase knowledge about post-approval changes,the technical requirements on post-approval change of vaccine products and other biological products are compared and analyzed in this paper,and some special considerations for the study of post-approval change of vaccine are refined.