European Commission Wants to Know: Is EMA’s Fee System Fair?

Regulatory NewsRegulatory News | 03 May 2018 |  By 

The European Commission on Thursday launched a public consultation as a part of a study evaluating the European Medicines Agency’s (EMA) fee system for approving and monitoring human and animal medicines.
Until 2 August, industry and other stakeholders can offer their input on whether EMA’s current fee and remuneration system is “cost-based, fair, proportionate and not unduly complex.”

Under this current system, EMA is funded by EU and European Economic Area (EEA) contributions, as well as by fees paid by entities for obtaining and maintaining marketing authorizations and for providing other services.

The cost of submitting marketing authorization applications (MAA) for human medicines typically begins at €286,900 ($343,634), while payments for scientific advice can range from €43,000 ($51,503) to €86,100 ($103,126).

This Commission consultation aims to elicit information, views and concerns on the fee system and its implementation, including the remuneration to national competent authorities.

“In particular, it seeks to gather input from groups having experience with the fee and remuneration system on its effectiveness and efficiency, relevance, coherence and sustainability,” the Commission said, noting that some of the questions are more specifically addressed to the pharmaceutical industry, academia and research organixations that have active experience with the operation of the EMA fee system.

The study, including the public consultation, is being carried out by RAND Europe.

Online questionnaire

Fees payable to the European Medicines Agency


© 2022 Regulatory Affairs Professionals Society.

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