Evaluation considerations on post-approval changes in registration standards of recombinant biological products
ZHAO Jing
QIU Xiao
WEI Wei
Abstract：Post-approval changes in registration standards of biological products are inevitable because of the increasing understanding of the products'quality attributes and the improving requirements of their controllability.The changes in the registration standards should aim to improve the controllability of drug quality,which need to meet the relevant regulations and cannot cause adverse effect on the drug qualities.Here,to provide references for the quality standard changes of the listed biological products,the classification criteria of the change types and key points including the changes in testing sites,testing items,analysis methods,and acceptable standard limits were first introduced.Then,the technical requirements for the relevant changes in registration standards were further elaborated by combining specific cases in the evaluations of quality standard changes in recombinant therapeutic biological products.
Keywords：quality standardpost-approval pharmaceutical changesclassification of the changeschange studyevaluation consideration
Publication Date：2024-05-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 868-873 )