EFPIA welcomes the adoption of the EMA Fees regulation report by the European Parliament at the July Plenary session of MEP Busoi (EPP, Romania).

Speaking about the proposal, Nathalie Moll, Director General EFPIA, said:   

"The revision of the EMA Fees regulation offers an opportunity to make Europe’s regulatory network more globally competitive by ensuring that sufficient financial resources go to the European Medicines regulatory network.”   

EFPIA supports a revision of the current fee system that is consistent with its fundamental principles of transparency, fairness & proportionality, sustainability, simplicity, and flexibility.  The objectives of streamlining the system, simplifying the fees structure, ensuring a sound financial basis to the EMA’s operations, and to make the system future-proof are all aligned with EFPIA’s position on EMA Fees.   

EFPIA continues to support a balance of simplification in fees administration while maintaining a proportionate cost-based approach. The funding of NCAs across the EU is critical to the efficient functioning of the system: the scientific expertise provided by the NCAs is a cornerstone of the EU’s central authorisation system, which should be adequately supported in the revised EMA fees proposals. Furthermore EFPIA is pleased to see that elements such as relevant performance indicators and consultations with stakeholders including the pharmaceutical industry have been carried forward into European Parliament’s position.  

Funding and financials are only a part of the current challenges facing the EU regulatory system’s resources along with many other contributors: recruiting technical expertise in cutting edge scientific/IT fields, growing new capabilities, retaining experienced talent, simplifying complex activities, and eliminating process redundancies. EFPIA’s Regulatory Road to Innovation seeks to comprehensively improve the system, reduce administrative burden and duplication. 

EFPIA looks forward to working with all policymakers and stakeholders to ensure a modernised EU regulatory system which would be able to adapt rapidly to emerging technology and needs of our healthcare systems.