What we do
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).
Corporate
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 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.
More on what EMA does:
- 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 has responsibilities for monitoring and mitigating potential or actual shortages of critical medicines caused by major events and in crisis situations.
The initial research on medicines is usually done by pharmaceutical and biotechnology companies – some big companies develop many medicines, while others are small companies who may only be researching one or two.
Doctors and academics also perform research, and may get together to research either new medicines or new uses of old medicines. Such researchers, either in public institutions or private companies, investigate vast numbers of substances for their potential as medicines each year.
However, only a small proportion of the compounds investigated will ever be promising enough to progress to further development.
 Did you know..? Developers of innovative treatments can discuss the scientific, legal and regulatory aspects of their medicine with EMA early in the development through the Innovation Task Force. In 2018 annual report of the European Medicines Agency, 9 of 22 such requests for early discussions came from university-based or academic groups. |
Potential new medicines are tested first in the laboratory and then in human volunteers, in studies called clinical trials. These tests help us to understand how the medicines work and to evaluate their benefits and side effects.
Medicine developers who wish to conduct clinical trials in the EU need to submit applications to the national competent authorities of the countries where they want to conduct the trials.
EMA does not have a role in the authorisation of clinical trials in the EU; this is the responsibility of the national competent authorities.
However, EMA, in cooperation with the EU Member States, plays a key role in ensuring that medicine developers follow EU and international standards.
Whether they conduct these studies within or outside the EU, developers conducting studies to support the marketing authorisation of a medicine in the EU have to comply with strict rules. These rules, called Good clinical practice, apply to the way they design the studies, how they record their results and how they report these results. These rules are in place to ensure that studies are scientifically sound and conducted in an ethical manner.
EMA cannot sponsor medicines or fund research studies for a specific medicine, nor can it force companies to research particular medicines or treatments for a particular condition.
Being a medicines regulator, EMA has to be neutral and cannot have a financial or other interest in any medicine being developed.
However, EMA can, and does, publicise areas where there is a need for new medicines – for example, new antibiotics – to encourage interested parties to research them. In addition, the EU legislation provides measures to encourage companies to develop medicines for rare diseases. These include for example fee reductions when obtaining scientific advice from EMA.
Also provided by the EU legislation is a system of obligations, rewards and incentives to encourage manufacturers to research and develop medicines for children.
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: Overview.
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 majority of medicines available in the EU are authorised at national level. For more information on medicine authorisation routes 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.
- evaluate medical devices. Medical devices are regulated by national competent authorities in Europe. EMA is involved in the assessment of certain categories of medical devices. For more information, see Medical devices;
- evaluate food supplements and cosmetics. These substances are evaluated at national level;
- carry out research or develop medicines. 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 or have information on the price or availability of medicines. Decisions about price and reimbursement take place at the level of each Member State in the context of the national health system of that country. For more information, see Health-technology-assessment bodies;
- control the advertising of medicines. The control of the advertising of non-prescription medicines in the EU is primarily conducted on a self-regulatory basis by industry bodies, supported by the statutory role of the national regulatory authorities in the Member States;
- control or have information on pharmaceutical patents. Patents having effect in most European countries may be obtained either nationally, via national patent offices, or via a centralised process at the European Patent Office;
- 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);
- provide medical advice. Healthcare professionals can provide individual patients advice on medical conditions, treatments or side effects with a medicine;
- 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.