FDA Encourages 'Established Conditions' Use Despite ICH Q12 Uncertainty
Go ahead and list the 'established conditions' in your NDAs, ANDAs and BLAs that require regulatory notification in the event of post-approval changes, which leaves all other CMC changes to be managed internally, FDA tells industry. But the agency wants a heads up if you're planning to do that, as the 'established conditions' paradigm continues to evolve in the context of ICH Q12 deliberations.
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The ‘established conditions’ concept enshrined in the ICH Q12 draft guideline was the US FDA’s answer to the background information that has cluttered new drug applications in the quality-by-design era. But early indications are that it will amass information clutter of its own.
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.
FDA draft 'conditions established' guidance proposes to smooth the way for continual improvement of manufacturing processes for drugs and biologics by saying which manufacturing changes don't need to be reported.