EU Ministers Back Greater Role For Member States In Updating EMA Fees
The Council of the EU has broadly accepted the European Commission’s proposal for a new, cost-based fee and remuneration system, but has suggested giving the European Medicines Agency’s management board – and hence the member states – a bigger role in future fee changes.
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EU ministers say that implementing an appropriate fee structure that is more in line with actual costs will promote innovation in the pharmaceutical sector while ensuring “fair access” to safe and effective medicines for patients.
Agreement on a new, more streamlined fee structure for the European regulator could be reached by the end of this year.
Medicines for Europe has urged the EU to reject European Council proposals to increase regulatory and pharmacovigilance fees, as part of an effort to simplify the fee structure at the European Medicines Agency.