EUROPEAN MEDICINES AGENCY (EMA)

The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.

Work

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.

Marketing Authorisations

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.

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 Eudra Vigilance and Eudra Vigilance 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 Pharmaoepidemiology 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 veterinary medicines, the EMA is also responsible for establishing safe limits for medicine residues in foods that come from animals.

Referrals

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.

Inspections

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).

Telematics

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.

Stimulating innovation

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 Organisation (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.

Agency structure

The EMA is headed by an Executive Director and has a secretariat of over 600 full-time staff. The Agency is governed by an independent Management Board. The Management Board consists of 35 members, who are appointed to act in the public interest and do not represent any government, organisation or sector. The Board sets the Agency’s budget, approves the annual work programme and is responsible for ensuring that the Agency works effectively and co-operates successfully with partner organisations across the EU and beyond. All Board members are required to make an annual declaration of any direct or indirect interests they have in the pharmaceutical industry. The Agency publishes these declarations of interest online.