New EMA Fees Could Shake Up Pharma Submission Strategies

01 Nov 2024

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.

Hour glass and calendar concept for time slipping away for important appointment date, schedule and deadline — Companies That Do Not Stick to Their Filing Plans Risk Incurring Additional Costs (Shutterstock)

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.

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Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

25 Apr 2025

• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.