EMA Fee Revisions Expected To Resolve EC's Objections To ICH Q12 Guideline
Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.
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An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.
Following a report that identified several shortcomings of the European Medicines Agency fee system, the European Commission has suggested various options to make it sustainable and future-proof.
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.