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EMA Fee Revisions Expected To Resolve EC's Objections To ICH Q12 Guideline

 
• By Bowman Cox

Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.

Euro currency
fee changes to liberate postapproval changes

The European Commission is considering revisions to the European Medicines Agency’s fee system that are expected to clear the way for final approval of the International Council for Harmonisation’s Q12 guideline on lifecycle management when the ICH meets 16-20 November in Singapore.

The expected revisions would likely enable the EC to remove its legal objections to portions of the draft Q12 guideline, sources say.

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