European Medicines Agency

The European Union agency that evaluates medicines for human and veterinary use and coordinates their safety monitoring.

Centralised procedure: An EU medicines-authorisation route that produces one marketing authorisation valid across the European Union. EMA scientific assessment through this route leads to a single EU-wide authorisation.
Marketing authorisation: Regulatory permission to place a medicinal product on the market under specified conditions. EMA recommendations support EU marketing authorisations for medicines assessed centrally.
European Union: A political and economic union of European countries with shared institutions and areas of common law. The EMA is an EU agency operating within the Union's regulatory system.
Decentralised procedure: An EU authorisation route in which several member states assess a medicine that has not yet been authorised anywhere in the EU. Unlike the centralised route, it is coordinated by national authorities rather than an EMA committee.
Committee for Medicinal Products for Human Use: The EMA committee responsible for evaluating human medicines and recommending EU marketing authorisations. It conducts the central scientific review of most medicines for human use.
Pharmacovigilance: The science and activities involved in detecting, assessing, understanding, and preventing adverse effects of medicines. The agency coordinates safety monitoring throughout a medicine's marketed life.
European Economic Community: A predecessor to the European Union established to integrate the economies of its member states. European medicine regulation developed through institutions created during the Community era.
Mutual recognition procedure: An EU route allowing a medicine authorised in one member state to be recognised in others. It extends a national authorisation instead of relying on the EMA's central assessment.
Pharmacovigilance Risk Assessment Committee: The EMA committee that assesses medicine safety issues and advises on risk management. It evaluates emerging safety evidence after medicines reach the market.
Orphan drug: A medicine developed to diagnose, prevent, or treat a rare disease, often with regulatory incentives. EMA designates orphan medicines and evaluates them for potential authorisation.

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