Global Post-Approval Changes Outlook Murky As Q12 Lurches Into Consultation
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.
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Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.
A final revision of the ICH Q12 lifecycle management guideline is expected to overcome a conflict with EU variations legislation and offer more clarity on what is, and what is not, an established condition subject to post-approval change reporting requirements.
Major pharmaceutical industry groups in the US, like their counterparts in the EU, are concerned that the draft ICH Q12 guideline does not align with the established legal framework in certain ICH regions, including the EU, in terms of implementing key concepts such as established conditions and product lifecycle management.