Why Industry Says Global Post-Approval Complexity Must Change
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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PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.
Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.
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.