EMA’s main role is to protect human and animal health:
- facilitate development and access to medicines;
- evaluate applications for marketing authorisation;
- monitor the safety of medicines across their life cycle;
- provide information on medicines to healthcare professionals and patients.
The European Medicines Agency (EMA) works closely with the human and veterinary medicines regulatory authorities of the Member States of the European Union (EU) and the European Economic Area (EEA).
The medicines regulatory authorities of the Member States, or “national competent authorities” (NCA), are responsible for the authorisation of medicines available in the EU that are not registered by the centralised procedure.
They also supply thousands of European experts who serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members.
This unique collaborative model, knows as the European medicines regulatory network (EMRN), enables Member States to pool resources and coordinate work to regulate medicines efficiently and effectively.
EMA also maintains close links with other European bodies such as EDQM and HMA.
EMA has seven scientific committees that evaluate medicines along their lifecycle from early stages of development, through marketing authorisation to safety monitoring once they are on the market.
In addition, the Agency has a number of working parties and related working groups, which the committees can consult on scientific issues relating to their particular field of expertise.
These bodies are composed of European experts made available by national competent authorities of the EU Member States, which work closely with EMA in the European medicines regulatory network.
For the veterinary side, the main committee is the Committee for Medicinal Products for Veterinary Use (CVMP). The Anses/ANMV is involved in many working groups arising from the CVMP.
Link to the EMA website: European Medicines Agency | (europa.eu)