For 2018, the total budget of the European Medicines Agency (EMA) amounts to €337.8 million. Around 90% of the Agency's budget derives from fees and charges, 7% from the European Union (EU) contribution for public-health issues and 3% from other sources.
Of the total budget in 2018:
approximately €304.5 million will come from fees and charges levied for regulatory services;
- approximately €22.4 million is expected in income from the EU, mainly to support the policies for orphan and paediatric medicines, advanced therapies and micro, small and medium-sized enterprises.
Fees from industry
The Agency charges a fee for processing applications from companies that want to bring a medicine to the market. It also charges fees for services related to the marketing of medicines in the EU in areas such as scientific advice, inspections and the establishment of maximum residue limits.
For more information, see Fees payable to EMA.
National medicines regulatory authorities
The Agency coordinates the scientific evaluation of applications and related work with the national medicines regulatory authorities in the EU Member States.
The Agency compensates the national authorities for this work and for the involvement of their staff members in the Agency's scientific committees, working groups and other activities.
In 2018, it is estimated that €127.6 million will be paid to the national medicines regulatory agencies from the Agency's budget.