European Medicines Agency

Organizational Structure

The Secretariat employs approximately 600 staff members who handle daily operations. Five units organize these workers including Directorate, Human Medicines Development and Evaluation, Patient Health Protection, Veterinary Medicines and Product Data Management, and Information and Communications Technology. A management board provides administrative oversight by approving budgets and selecting the executive director. This Board includes one representative from each of the 27 Member States. Two representatives come from the European Commission while another two represent the European Parliament. Patients' organizations receive two seats on the board alongside one seat for doctors' organizations and one for veterinarians' organizations. Seven scientific committees form the heart of the agency's work. These include human medicines, veterinary medicines, herbal products, orphan drugs, paediatrics, advanced therapies, and pharmacovigilance risk assessment. About 4500 experts throughout the EU participate in a decentralized network. The agency draws resources from over 40 National Competent Authorities across member states.

When was the European Medicines Agency established and what regulation created it?

The European Union established the agency in 1995 under EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products.

Where is the European Medicines Agency located after Brexit and when did the move complete?

The European Medicines Agency relocated to Amsterdam with permanent building completion occurring by January 2020 following a final decision on the 20th of November 2017.

What date did the European Medicines Agency authorize the Pfizer BioNTech COVID-19 vaccine?

The European Medicines Agency authorized the vaccine on the 21st of December 2020 after determining product quality was sufficiently consistent and acceptable.

How many staff members work at the European Medicines Agency and how are they organized?

The Secretariat employs approximately 600 staff members who handle daily operations across five units including Directorate Human Medicines Development and Evaluation Patient Health Protection Veterinary Medicines and Product Data Management and Information and Communications Technology.

Which medicines require centralised authorization through the European Medicines Agency?

Centralised procedure is compulsory for biotechnology-derived medicines treatments for HIV/AIDS cancer diabetes neurodegenerative diseases viral infections gene therapy somatic cell therapy tissue engineered medicines and orphan medicines for rare diseases.

European Medicines Agency.

Organizational Structure

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Common questions

When was the European Medicines Agency established and what regulation created it?

Where is the European Medicines Agency located after Brexit and when did the move complete?

What date did the European Medicines Agency authorize the Pfizer BioNTech COVID-19 vaccine?

How many staff members work at the European Medicines Agency and how are they organized?

Which medicines require centralised authorization through the European Medicines Agency?

Regulatory Procedures

Relocation To Amsterdam

Pandemic Response And Cyberattack

Global Comparisons And Criticism