The European Medicines Agency's (EMA) main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
The Agency is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure.
Under the centralised procedure, pharmaceutical companies submit a single marketing-authorisation application to the EMA. Once granted by the European Commission, a centralised marketing authorisation is valid in all European Union (EU) Member States, as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. By law, a company can only start to market a medicine once it has received a marketing authorisation.
- For information on the types of medicines that fall under the centralised procedure, see central authorisation of medicines.
Most of the EMA's scientific evaluation work is carried out by its scientific committees, which are made up of members from EEA countries, as well as representatives of patient, consumer and healthcare-professional organisations. These committees have various tasks related to the development, assessment and supervision of medicines in the EU.
In total, the Agency works with a network of over 4,500 European experts, which includes the members of the Agency's scientific committees, as well as its working parties and other groups. These experts are made available to the EMA by the medicines regulatory authorities in EEA countries.
Safety monitoring of medicines
The EMA is responsible for coordinating the EU's safety-monitoring or 'pharmacovigilance' system for medicines. It constantly monitors the safety of medicines through the EU network and can take action if information indicates that the benefit-risk balance of a medicine has changed since it was authorised.
The EMA has a Pharmacovigilance Risk Assessment Committee (PRAC), which provides recommendations on the safety of human medicines. The Committee for Medicinal Products for Veterinary Use (CVMP) and its Pharmacovigilance Working Party deal with safety issues for veterinary medicines.
The Agency works through:
- providing specific support to pharmacovigilance activities for centrally authorised products, in particular through risk-management plans;
- developing guidelines and setting standards;
- coordinating the monitoring of pharmaceutical companies' compliance with their pharmacovigilance obligations;
- informing the public on the safety of medicines and cooperating with all external parties, in particular through the Agency's interaction with representatives of patients and healthcare professionals;
- contributing to international cooperation activities with authorities outside the EU.
The EMA is also responsible for developing and maintaining EudraVigilance and EudraVigilance Veterinary, the EU reporting and data-storage systems for side-effect reports, and for supporting signal-identification activities in the EU, including coordinating the EU rapid-alert and incident-management systems for responses to new safety data.
It also supports methodological research, managing the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). This network aims to strengthen the monitoring of authorised medicines in Europe by facilitating the conduct of multicentre, independent, post-authorisation studies focusing on safety and on the balance of benefits and risks.
For more information, see safety monitoring of medicines.
For veterinary medicines, the EMA is also responsible for establishing safe limits for medicine residues in foods that come from animals.
The EMA's committees are involved in referral procedures to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines.
In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. The matter is ‘referred’ to the EMA so that it can make a recommendation for a harmonised position across the EU.
If a referral is based on safety concerns, the matter is assessed by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA's committee responsible for assessing and monitoring safety issues for human medicines. Urgent matters are addressed through an urgent Union procedure designed to rapidly assess significant emerging safety issues linked with a medicine available in the EU regardless of its initial authorisation route, either central or national.
Disagreements among Member States on the use of a medicine can also be referred to the EMA. Referrals can be started by the European Commission, any Member State or by the company that markets the medicine.
For more information, see:
The Agency is responsible for coordinating inspections requested by its committees in connection with the assessment of marketing-authorisation applications or referrals. These inspections may cover:
- good manufacturing practice (GMP);
- good clinical practice (GCP);
- good laboratory practice (GLP);
- pharmacovigilance (PhV).
Inspections aim to verify specific aspects of the clinical or laboratory testing of a medicine, its manufacture or control, or to ensure compliance with GMP, GCP, GLP or pharmacovigilance quality-assurance systems.
Inspections can also be performed in the context of the certificaton of vaccine antigen master files (VAMF) or plasma master files (PMF).
- For more information, see inspections.
The EMA is responsible for implementing the EU telematics programme. EU telematics are a central set of pan-European systems and databases whose use is limited only by legal or confidentiality requirements.
The telematics systems exchange information with the systems of external stakeholders and European regulatory authorities, helping to provide high-quality information on medicines to the general public and support the monitoring of the post-authorisation benefit-risk balance of medicines in the EU.
- For more information, see telematics programme.
The Agency plays a role in stimulating innovation and research in the pharmaceutical sector:
- it gives scientific advice to companies on the development of new medicines;
- it publishes guidelines on the requirements for the quality, safety and efficacy testing of medicines;
- it provides special assistance to micro, small and medium-sized enterprises (SMEs) through its SME office;
- it issues opinions on orphan designation for medicines for rare diseases;
- it manages the Innovation Task Force, a group that provides a forum for early dialogue with applicants.
The European network
The EMA is the hub of a European medicines network comprising:
- over 40 national regulatory authorities;
- the European Commission;
- the European Parliament;
- other decentralised EU agencies.
The EMA works closely with its European partners to build the best possible regulatory system for medicines for Europe and protect the health of its citizens.
The Agency works to forge close ties with partner organisations around the world, including the World Health Organization (WHO) and the regulatory authorities of non-European nations. These activities aim to foster the timely exchange of regulatory and scientific expertise and development of best practices in the regulatory field across the world.
The EMA is headed by an Executive Director and has a secretariat of over 600 full-time staff. The Management Board is the supervisory body of the Agency, responsible, in particular, for budgetary matters.
- For more information, see Agency structure.
What the Agency does not do
We do not evaluate all medicines in use in the EU
The Agency is involved in the scientific evaluation of medicines that fall within the scope of the centralised authorisation procedure. However, thousands of other medicines that do not fall within this scope are marketed in the EU in individual EU Member States in accordance with national authorisation procedures not involving the EMA, or in several Member States through the decentralised or mutual recognition procedures.
The mutual recognition and decentralised procedures are overseen by two coordination groups representing the EU Member States: the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv).
The Agency can become involved in assessing nationally authorised medicines if they are referred to the EMA through a referral procedure. This may be due to a safety concern or an issue that requires resolution in the interest of protecting public health. Significant emerging safety issues concerning a medicine marketed in the EU can be referred to the Agency under the urgent Union procedure regardless of the medicine's initial authorisation route. For more information, see:
We do not research or develop medicines
The Agency does not research or develop medicines. It also does not operate laboratories on its premises or elsewhere for this work, and is not involved in conducting clinical trials.
Research and development work on medicines is carried out by pharmaceutical companies or other medicines developers themselves. They then then submit the findings and test results for their products to the Agency for evaluation.
The EMA's role in this area is limited to providing certain services to stimulate innovation and support the development of safe and effective medicines in the EU, including providing scientific advice and protocol assistance and support to research activities.
The EMA does not directly fund research. If you are looking for information on research funding opportunities in the field of medicine, you may be interested in:
We do not influence the price or availability of medicines
The Agency is not responsible for reviewing pricing or reimbursement issues, or for making decisions on the availability of medicines in European countries. These issues are handled at national level in individual EU countries.
National organisations called health-technology-assessment (HTA) bodies carry out their own assessments of medicines that have received a marketing authorisation. HTA bodies make recommendations on the medicines and other health interventions that can be paid for or reimbursed by the healthcare system in a particular Member State. They compare the relative effectiveness of medicines, in order to assess their usefulness to the healthcare system in their territory. Some HTA bodies also take the financial cost of medicines into account, in accordance with national legislation.
We do not develop treatment guidelines
The EMA is not mandated to develop guidelines on how to treat or manage specific diseases (sometimes known as clinical guidelines). This is done by national governments or the health authorities of individual EU Member States.
We do not establish ethical codes
The Agency’s scientific committees are not responsible for establishing ethical codes of conduct relating to the research or development of medicines. Issues relating to ethics are established through legislation, taking account of relevant advice from the European Group on Ethics in Science and New Technologies. Requirements for the conduct of clinical trials in the European Union (EU) are implemented in the 'Clinical Trial Directive' (Directive 2001/20/EC) and the 'good-clinical-practice Directive' (Directive 2005/28/EC). Good clinical practice is an international ethical and scientific quality standard for conducting clinical trials.
All the clinical data submitted to the EMA to support a marketing-authorisation application must be based on studies that comply with the ethical standards for clinical trials. As part of the evaluation process, the EMA checks that these standards have been respected. For more information, see:
We do not develop laws or policies concerning medicines
The Agency does not develop or adopt new laws or change existing laws concerning medicines. EU legislation concerning medicines is developed by the European Commission and adopted by the European Parliament together with the Council of the European Union. EU policies in the field of human or veterinary medicines and public health are developed by the European Commission. For more information see:
We do not issue marketing authorisations
The Agency provides scientific opinions, but it is not responsible for issuing decisions on whether to grant, suspend or revoke a marketing authorisation for any medicine.
For centrally authorised medicines, this type of legal decision is issued by the European Commission.
For nationally authorised medicines, this type of legal decision is issued by the national competent authorities of the EU Member States.
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