Discussion on the research of supplemental applications for post-approval oral modified-release formulations
SI Xiaofei
WANG Shuhua
LI Yanjie
JIANG Dianzhuo
Abstract：The post-approval CMC(chemical,manufacturing and control)changes are important parts of pharmaceutical product lifecycle.The changes considered to have a substantial potential to have a significant effect on safety,efficacy and quality of modified-release formulations.The pharmaceutical sponsors who intend to change the batch size,specification,storage condition and strength of some oral modified-release formulations should submit supplemental applications for major changes.Based on specific cases of oral modified-release formulations,the pharmaceutical considerations were put forward to assess the effects of the change and change research,in order to provide references for conduct change research and management.
Keywords：Post-approval changeOral modified-release formulationsSupplemental applicationsChange research
Publication Date：2026-02-28
Online Publishing Date：2026-03-25(First online date of this platform, not the publication date of the document)
Pages：5( 188-191,229 )