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An Evaluation of Postapproval CMC Change Timelines

ISPE

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.