Several special considerations on the registration of post-approval changes for vaccines based on lifecycle management
JIN Su
GUO Sheng-nan
QIU Xiao
GUO Shu-yang
YIN Xiao
XIANG Jin-zhong
LI Min
Abstract：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.
Keywords：vaccinepost-approval changechemical manufacturing and controltechnical requirementschange of registration
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2457-2462 )