An Evaluation of Postapproval CMC Change Timelines
ISPE
SEPTEMBER 10, 2023
In this article, we describe the assessment of lag time for global regulatory approvals of postapproval CMC changes for multiple products over a three-year period. Mission: Harmonisation for Better Health.” www.ich.org/page/mission 5 Beierle, J., Bolivia, Hong Kong, Malaysia, Philippines, and Vietnam). Cauchon, T.
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