EFPIA response to EU Commission proposal for revised EMA Fees regulation

EFPIA welcomes the opportunity to provide feedback on the EU Commission proposal for a revised EMA Fees regulation.  

Speaking about the proposal, Pär Tellner, Director Regulatory, Drug development and manufacturing, EFPIA, said:  

Industry considers it essential to the viability of the EU regulatory system that the Network be strengthened by the necessary resources, funding, infrastructure and expertise. The EMA fees system functions as a central resource enabler requiring regular updates over time."

The COVID-19 pandemic has highlighted the importance of a robust, resourced, efficient, and adaptable regulatory system. Significant resourcing challenges are faced today by the EU regulatory Network and it is essential that EMA and National Competent Authorities (NCAs) have the necessary resources and infrastructure to deliver their public health mission.  

Mark Mayer, co-chair of the EFPIA Fees policy group and Assoc. VP, Global Regulatory Policy, Eli Lilly and Company, said:  

"The revision of the EMA Fees regulation offers an opportunity to make Europe’s regulatory network more globally competitive, and help deliver for patients by becoming faster, more efficient and flexible.”  

EFPIA members support 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 the proposal to streamline the system, to simplify the fees structure, to contribute to providing a sound financial basis to the EMA’s operations, and to make the system future-proof are aligned with EFPIA’s position paper on EMA Fees.  

For example, EFPIA supports the introduction of a new fee for the assessment of pre-submission data packages on an on-going basis as it advances regulatory and data sciences, and timelier new and innovative medicines for EU patients. 

A more agile EMA fee system is being proposed by the Commission that seeks to adjust the fees with increased flexibility based on advances in regulatory science and progression of policies to enable innovation.  

To ensure optimal agility, it will be important that sufficient transparency is part of the future fees revision process, together with adequate performance indicators and consultations with stakeholders, including the pharmaceutical industry. EFPIA also proposes the establishment of a platform for ongoing consultation.  

EFPIA continues to support a balance of fees administration simplification with proportionate cost-based fees. We are pleased that this goal has been carried forward into the current proposed provisions. 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. 

Finally, 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."