impact assessment

Impact assessment of the EMA fees system

In Projects by Elta Smith

The European Medicines Agency (EMA) provides scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA fees system helps to ensure a sound financial basis for the assessments underpinning EU medicines authorisations. It also supports other services related to medicinal products.

fees system

I coordinated a study for the impact assessment of the fees system. This was led by ICF and RAND Europe for the European Commission, Directorate General for Health and Food Safety.

The study involved desk research and consultation with stakeholders at national and EU levels (surveys and interviews), and development of a model of the system. It also included a monitoring and evaluation framework to assess the financial stability of the system in the future.

View more projects