An Evaluation of Postapproval CMC Change Timelines
ISPE
SEPTEMBER 10, 2023
In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. On this basis, country approvals covering 2016–2020 were included in the analysis. 2 3 7 Pezzola, A., Globalization and Health 12, no.
98 
Let's personalize your content