The European Commission is currently conducting a public consultation on the EMA fee system, open until the 2nd August. The consultation is in support of a study by RAND Europe, commissioned by DG SANTE, to assess whether the fees are economic, fair, and avoid an excessive administrative burden on fee payers. Based on this, the EC will then consider if any reforms of the current system are necessary.
The European Medicines Agency (EMA) is the EU’s central regulatory body operating authorisation procedures for human and veterinary medicinal products across the EU and EEA. Currently, the EMA is funded by EU and EEA contributions, in addition to fees paid by medicine manufacturers. The cost of submitting marketing authorization applications (MAA) for human medicines typically begins at €286,900 ($343,634), while payments for scientific advice can vary from €43,000 ($51,503) to €86,100 ($103,126).These are primarily used to finance assessments relating to the granting, maintaining and monitoring EU market authorisations, along with other services such as pharmacovigilance at an EU level. The EMA works in close collaboration with national competent authorities (NCAs) in the EU and EEA Member States, who are represented in the EMA committees and working parties.
All individual contributions will be published on the Commission’s website upon finalisation of the public consultation. The identity of the respondent will only be published with their active consent. All citizens, administrations, associations and other organisations with an interest in the EMA fee system and its implementation are encouraged to participate.