Registration management of post-approval changes of production site of biological drug substance in China
JIANG Dan-li
LIN Lin
TIAN Li-juan
Abstract：To discuss the risk types,study contents and registration management of change of drug substance's production site of post-approval biologic products in China,and provide reference for companies which may conduct the same type of change.By combing regulation/guidance interpretation,literature analysis and previous job experience,the authors sorted out the principle for classification of major change of drug substance's production site of post-approval biologic products in China and summarized suggestions for comparability study and personal experience in the registration management.In view of the above changes,the sponsor should collect and assess as much data as possible before conducting change and analyze the possible impact of changes.Non-clinical and clinical bridging study would be not necessary if the comparability studies of pre-post change on chemistry,manufacture and control prove that site change does not affect the safety and efficacy of the product.
Keywords：post-approval biologicsdrug substanceproduction site/company changecomparability studyregistration management
Publication Date：2024-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2550-2554 )