European Medicines Agency
EMA is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area (EEA), by ensuring that all medicines available on the EU market are safe, effective and of high quality.
EMA serves a market of over 500 million people living in the EU.
The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).
Facilitate development and access to medicines
- EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients.
- The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.
- EMA also plays a role in supporting research and innovation in the pharmaceutical sector, and promotes innovation and development of new medicines by European micro-, small- and medium-sized-enterprises.
Evaluate applications for marketing authorisation
- EMA's scientific committees provide independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data.
- The Agency's evaluations of marketing-authorisation applications submitted through the centralised procedure provide the basis for the authorisation of medicines in Europe.
- They also underpin important decisions about medicines marketed in Europe, referred to EMA through referral procedures. EMA coordinates inspections in connection with the assessment of marketing-authorisation applications or matters referred to its committees.
Monitor the safety of medicines across their lifecycle
EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks. The Agency works by:
- developing guidelines and setting standards;
- coordinating the monitoring of pharmaceutical companies' compliance with their
- pharmacovigilance obligations;
- contributing to international pharmacovigilance activities with authorities outside the EU;
- informing the public on the safety of medicines and cooperating with external parties, in particular representatives of patients and healthcare professionals.
Provide information to healthcare professionals and patients
- The Agency publishes clear and impartial information about medicines and their approved uses.
- This includes public versions of scientific assessment reports and summaries written in lay language.
ESE actively supports the EMA, representing the European endocrine community by participating in surveys, working groups and meetings as well as disseminating information from the agency to our members and other interested parties.