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. For more information see:
- support for early access;
- scientific advice and protocol assistance;
- paediatric procedures;
- scientific support for advanced-therapy medicines;
- orphan designation of medicines for rare diseases;
- scientific guidelines on requirements for the quality, safety and efficacy testing of medicines;
- the Innovation Task Force, a forum for early dialogue with applicants.
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.
For more information see Pharmacovigilance.
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. For more information see:
What we don't do
Not all aspects of medicine regulation in the EU fall under the remit of the Agency. EMA does not:
- evaluate the initial marketing authorisation application of all medicines in the EU. The vast majority of medicines available in the EU are authorised at national level, either because they were authorised before EMA’s creation or they were not in the scope of the centralised procedure the Agency is responsible for. For more information on the authorisation routes of medicines in the EU, see Authorisation of medicines;
- evaluate applications for the authorisation of clinical trials. The authorisation of clinical trials occurs at Member State level, although the Agency plays a key role in ensuring that the standards of good clinical practice are applied in cooperation with the Member States and manages a database of clinical trials carried out in the EU.
- carry out research or develop medicines. EMA does not operate laboratories on its premises or elsewhere, and is not involved in conducting clinical trials. Pharmaceutical companies or other medicines developers carry out the research and development of medicines, who then submit the findings and test results for their products to the Agency for evaluation;
- take decisions on the price or availability of medicines. Once a marketing authorisation has been granted, decisions about price and reimbursement take place at the level of each Member State considering the potential role and use of the medicine in the context of the national health system of that country. For more information, see Health-technology-assessment bodies;
- develop treatment guidelines. National governments or the health authorities of individual EU Member States develop guidelines for decisions regarding diagnosis, management, and treatment in specific areas of healthcare (sometimes known as clinical guidelines);
- develop laws concerning medicines. The European Commission develops EU legislation concerning medicines and the European Parliament together with the Council of the European Union adopt it. The European Commission also develops EU policies in the field of human or veterinary medicines and public health. For more information see European Commission: Medicinal products for human use;
- issue marketing authorisations. The legal decision to grant, suspend or revoke a marketing authorisation for any medicine falls under the remit of the European Commission for centrally authorised products, and the national competent authorities of the EU Member States for nationally authorised products.
EMA often receives questions about the scope of its work. See a list of Frequently asked questions.
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