European Medicines Agency

European Medicines Agency (EMA) is a European Union agency responsible for the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or EMEA.

History

The EMA was established in 1995 with the aim to harmonize the supervision of medicinal products in the EU. It replaced the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, although both of these committees still exist within the EMA structure.

Function

The EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (a process known as the 'centralised procedure'). Once granted by the European Commission, a centralised (or 'Community') marketing authorisation is valid in all EU Member States, the European Economic Area-EFTA states (Iceland, Liechtenstein and Norway) and the UK.

Structure

The EMA operates as a decentralised scientific agency (as opposed to a regulatory authority) of the EU and is governed by a Management Board. The Board is composed of representatives of EU Member States, the European Commission, the European Parliament, patient organizations, and healthcare professionals.

Location

The EMA was originally located in London, United Kingdom, but moved to Amsterdam, the Netherlands, in March 2019 due to the UK's decision to leave the EU (Brexit).

Criticism and Controversy

The EMA has faced criticism over its handling of safety issues with approved drugs, with some critics claiming that the agency is too quick to approve drugs and too slow to withdraw them once problems become apparent.

See also

• Pharmaceutical industry in the European Union
• Regulation of therapeutic goods
• Food and Drug Administration (US equivalent)
• European Centre for Disease Prevention and Control
• European Institute of Innovation and Technology
• European Food Safety Authority

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