The European Medicines Agency's 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 Agency. 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 Agency'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 Agency by the medicines regulatory authorities in EEA countries.
Safety monitoring of medicines
The Agency 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 Agency 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 Agency 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 Agency is also responsible for establishing safe limits for medicine residues in foods that come from animals.
The Agency'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 European Medicines Agency is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. The medicine, or the class or medicines, is ‘referred’ to the Agency so that it can make a recommendation for a harmonised position across the EU.
There are a number of reasons why a referral may be started, ranging from concerns over the safety of a class of medicine to disagreements among Member States on the use of the medicine. 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 Agency 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 Agency 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 Agency 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 Agency 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
Evaluate all medicines in use in the EU
The Agency is involved in the scientific evaluation of the medicines that fall within the scope of the centralised procedure. However, thousands of other medicines that do not fall within this scope are marketed in the EU in individual Member States in accordance with their national authorisation procedures, or in multiple Member States through the decentralised or mutual-recognition procedures.
The Agency only becomes involved in the assessment of nationally authorised medicines when they have been referred to the Agency due to a disagreement between two or more Member States or due to some other issue that requires resolution in the interest of protecting public health.
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.
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.
Evaluate the pricing or availability of medicines in individual countries
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 dealt with by the national governments or health authorities of individual countries.
Establish ethical codes or evaluate applications based on ethical considerations
The Agency’s scientific committees are not responsible for establishing ethical codes of conduct relating to the research or development of medicines, or for evaluating applications based on ethical considerations.
Issues relating to ethics are established through legislation and directives set by the European Parliament, based on proposals from the European Commission, which in turn is advised by the European Group on Ethics in Science and New Technologies.
As part of the initial administrative evaluation of the dossier of a marketing-authorisation application, the Agency’s role is to ensure that previously determined standards and regulations have been implemented.
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