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.
Key Takeaways
- A regulation on charges payable by drug companies to the European Medicines Agency establishes new fees for pre-submission activities and delays to planned marketing authorization applications (MAAs).
- The regulation will come into effect on 1 January 2025.
- Under the regulation, each change in the intended MAA submission date that goes beyond 60 days than what initially specified by the company will attract a fee
Regulation (EU) 2024/568 introduces new fees – involving €4,200 ($4,560) per change – that companies will have to pay if they change their MAA submission date by more than 60 days beyond what was initially specified
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