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EU Fees Revision A ‘Once-In-A-Generation’ Chance To Solve Resource Challenges

 
• By Ian Schofield

COVID-19 and Brexit have put a great strain on the resources of the EU medicines regulatory system, but the planned review of the EU fee system could produce a system that is more flexible, efficient and better able to respond rapidly to emerging technologies and the needs of health care systems, says EFPIA.

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The EU is changing the way it charges fees for drug regulatory services • Source: Shutterstock

Proposals to overhaul and simplify the EU’s complex fee framework, under which fees would be more transparent and reflect the actual costs of regulatory services, have been hailed by the R&D-based industry federation EFPIA as a chance to make the EU regulatory system more flexible, efficient and internationally competitive.

Many aspects of the fee proposals are “well aligned” with EFPIA’s “fundamental principles of transparency, fairness & proportionality, sustainability, simplicity,...

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