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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Industry and regulatory working group participants are grappling with established conditions and post-approval change management protocols in developing early ICH Q12 draft guidance. Latest proposal calls for three post-approval change categories.
ICH updates progress made on quality guidelines; EMA talks combination products; UK MHRA report sheds light on GMP deficiencies; MHRA official describes compliance escalation; FDA guides microbiology reviewers through Common Technical Document; FDA OKs reliance on non-USP compendia in applications.
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.