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Why Industry Says Global Post-Approval Complexity Must Change

Executive Summary

Post-approval nightmares shared in biopharmaceutical CMC strategy session. One firm's 'impossible' task: making a drug 55 different ways for 105 countries.

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Ambitious effort to enable fuller, quicker rollout of post-approval manufacturing changes progressed at ICH meeting in Lisbon, participants told recent conferences. Much of the focus of ICH Q12 discussion was on harmonized reporting categories so manufacturers could make more changes before obtaining approval – and in some cases without even seeking approval.

ICH Q12 Experts Develop Four-Tier Scheme For Harmonizing Post-Approval Changes

Ambitious effort to enable fuller, quicker rollout of post-approval manufacturing changes progressed at ICH meeting in Lisbon, participants told recent conferences. Much of the focus of ICH Q12 discussion was on harmonized reporting categories so manufacturers could make more changes before obtaining approval – and in some cases without even seeking approval.

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