Final ICH Q12 Post-Approval Changes Guideline Expected In November
Legal Impasse Likely To End, Established Conditions Sure To Be Clarified
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.
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Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.
While reservations are still being expressed on ICH Q12, the pharmaceutical industry is busily preparing for ICH Q12 implementation.
Anticipating the eventual adoption of ICH Q12, the US FDA is training staff on some of its key principles. An agency official says ICH Q12 necessitates a new way of thinking about and reviewing regulatory submissions for post-approval changes and such training is necessary to ensure review consistency.