The European Medicines Agency’s new fee regulation, which is due to come into effect on 1 January 2025, may force drug companies to reconsider their current strategies for determining submission dates for the marketing authorization applications (MAAs) they file for evaluation via the EU’s centralized procedure.
New EMA Fees Could Shake Up Pharma Submission Strategies
Companies that delay their drug application submissions to the European Medicines Agency by more than 60 days will face an additional fee of €4,200 per delay under a new regulation effective from 2025.
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