Generics Firms Seek To Establish Better Conditions For Post-Approval Change Flexibility
Concerns raised around defining ICH Q12 “established conditions” for post-approval changes and potential role of prior knowledge for legacy products discussed in the context of generic drug applications; likely residual lack of harmonization explored.
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Upcoming ICH Q12 implementation guidance will translate terminology on post-approval changes into a US context, said a US FDA official who also shared some lessons learned on established conditions.
ICH finally proposes a way to resolve the regulatory complexity that has prevented drug makers from establishing and perfecting global approaches to manufacturing their drug products. But with legal concerns persisting in Europe and possibly lurking elsewhere, approval of ICH's draft Q12 guideline could be difficult.
Objections to 15 February reporting date established in draft guidance spurred rare last-minute notice assuring industry that it was a non-binding recommendation, not a requirement. Action reflects confusion that can arise in interpreting policy guidance.