European Union agencies
The European Medicines Agency (EMA) works closely with other decentralised agencies of the European Union (EU), particularly those with similar areas of work.
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EU agencies carry out specific legal, technical or scientific tasks. They work alongside the main EU institutions and Member States, providing them with evidence-based advice to help inform policies and laws at European and national levels.
The heads of the EU agencies set up the EU Agencies Network to act as a collective voice for the agencies.
Through the network, the agencies coordinate their activities, exchange information and agree common positions on matters of shared interest.
EMA and other EU agencies regularly cooperate on joint scientific outputs and exchange support or scientific data to feed into each other's work.
EMA has formal working arrangements with its main EU agency partners, laying out the nature of the collaboration and mutual consultation in areas of common interest. These agencies regularly run joint projects and participate in each other's events and meetings.
European Centre for Disease Prevention and Control (ECDC)
ECDC's mission is to identify, assess and communicate current and emerging threats to human health posed by infectious diseases. Collaboration between EMA and ECDC mainly relates to:
- information on vaccines, antimicrobial resistance and antiviral medicines;
- monitoring the benefit-risk balance of vaccines;
- substances of human origin, such as the use of human tissue or cells in medicines.
The agencies signed a working arrangement in December 2010:
In 2023, EMA and ECDC signed a technical annex to the existing working arrangements to describe their respective roles and responsibilities as regards the implementation of the Vaccines Monitoring Platform:
ECDC has developed the European Vaccination Information Portal (EVIP) with the support of EMA and the European Commission.
EVIP provides accurate, objective and evidence-based information on vaccines and vaccination, including national vaccination schedules. It went live in April 2020 and is available in all official EU languages.
The portal was developed following a Council Recommendation to address the concerns and doubts of European citizens in an easily accessible language.
EFSA provides independent scientific advice and communication on existing and emerging risks relating to the safety of food and animal feed. Collaboration between EMA and EFSA mainly relates to:
- potential conflicts in scientific opinions;
- the use of antibiotics in food-producing animals;
- joint scientific guidance;
- risk communication;
- governance and reporting.
The agencies signed a working arrangement in January 2012:
European Chemicals Agency (ECHA)
ECHA seeks to help companies comply with chemicals legislation, advance the safe use of chemicals, address chemicals of concern and provide information on chemicals, all for the protection of human health and the environment. Collaboration between EMA and ECHA mainly relates to:
- information on the evaluation and authorisation or restriction of chemicals, as relevant for the activities of EMA;
- information concerning risk management through classification, labelling and packaging of substances;
- toxicological assessments by predictive methods and new methodologies;
- biocides, in particular the establishment of maximum residue limits for pharmacologically active substances contained in biocidal products used in animal husbandry;
- environmental risk assessments for both human and veterinary medicines and ecotoxicology.
The agencies signed a working arrangement in May 2014:
European Union Drugs Agency (EUDA)
EUDA contributes to EU preparedness on illicit drugs by:
- carrying out actions to anticipate and alert on threats;
- responding to emerging drug-related issues;
- learning from best practice in the field to assess the effectiveness of interventions.
Collaboration between EMA and EUDA mainly relates to:
- information on new psychoactive substances and abuse of medicines, including illicit drugs;
- validated signals with medicines related to drug abuse;
- definition of risk management plans of selected medicines on an ad-hoc basis;
- potential conflicts over scientific opinions.
EUDA was formerly known as the European Union Monitoring Centre for Drugs and Drug Addiction (EMCDDA).
EMA and EMCDDA first signed an official working arrangement in 2010. The agencies revised the arrangement in 2012, following the adoption of the new pharmacovigilance legislation, to allow the exchange of information on the abuse of medicines, including psychoactive substances.
The agencies further revised the arrangement in 2018 to reflect the streamlined process for collecting information on psychoactive substances introduced in EMCDDA's founding regulation.
The working arrangement between EMA and EMCDDA will be updated to reflect the new EUDA Regulation in due course.
European Environment Agency (EEA)
EEA provides independent, reliable and comparable environmental information on the state and trends of the European environment for those involved in developing, adopting, implementing and evaluating environmental policy, and also the general public.
EMA and EEA can cooperate on issues of common interest on an ad-hoc basis.