New EU Fee System To Give Pharma Firms More Predictability

The publication of a draft EU Regulation governing the fees paid by the pharmaceutical industry to the European Medicines Agency is the latest step in a long process aimed at ensuring that the payment system better reflects the actual costs of the regulatory work carried out or coordinated by the EU regulator.

fees text displayed on calculator and magnifier.
The EMA's fee structure is being revised • Source: Shutterstock

The European Commission has put out for consultation a set of formal proposals for simplifying the fee system that is used to fund the regulatory activities of the European Medicines Agency and the EU medicines regulatory network.

The updated system would align fees more closely with costs, spread the financial burden of fee reductions, and give pharmaceutical companies more visibility in terms of fees to be charged...

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