BIA submission to the European Commission in response to the consultation on the evaluation of the European Medicines Agency fee system

The European Commission launched in May a public consultation to gather stakeholders views on the EMA fee system – fees paid by industry for EMA activities relating to the approval and monitoring of medicines, as well as the remuneration to national competent authorities (NCAs) for the assessment of centralised marketing authorisation applications and performing regulatory services including pharmacovigilance at EU level.  

Findings will feed into a study, conducted by RAND Europe on behalf of the European Commission’s DG SANTE, to assess the extent to which the current EMA fee and remuneration system is cost-based, fair, proportionate and not unduly complex.

BIA has worked in collaboration with EuropaBio to develop a consolidated response based on members input.