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New EU Fee Regulation: Smaller Firms & Orphan Drugs Will Still Benefit From Full Reductions

 
• By Eliza Slawther

While annual fees for marketing authorization applications and annual payments to the European Medicines Agency are set to increase from 2025, micro-sized companies and SMEs that make orphan drugs will still benefit from full reductions.

Micro-sized companies and small and medium-sized enterprises (SMEs) whose products have an orphan designation will still benefit from a 100% annual fee reduction under the European Medicines Agency’s new EU fees regulation, which is due to come into effect on 1 January.

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