Study for the Evaluation of the EMA Fee System

The European Medicines Agency (EMA) is the European Union's (EU) central regulatory body to enable centralised authorisation procedures for medicinal products for use in humans and food-producing animals across the European Economic Area (EEA). The agency is funded by general EU and EEA contributions as well as fees paid by industry for obtaining and maintaining marketing authorisations and providing other authorisation-related services. The EMA works in close collaboration with national competent authorities (NCAs) in EEA Member States, which undertake activities related to assessments aimed at granting, maintaining and monitoring EU marketing authorisations, and other services related to medicinal products for human and veterinary use including pharmacovigilance activities for medicines for human use at EU level. NCAs are remunerated by the EMA for undertaking these activities.

The fee and remuneration system is defined in Council Regulation (EC) No 297/95, which establishes the services provided by the EMA and related fees payable to the agency for undertaking authorisation procedures, as well as through a set of implementing rules and Regulation (EU) No 658/2014 for pharmacovigilance activities. The fee system also provides fee incentives and reductions for specific types of products including orphan designated medicines, veterinary medicines, products for paediatric use, and advanced therapy medicinal products and for specific user groups such as micro, small and medium-sized enterprises (SMEs).