European Medicines Agency (EMA)

Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.

European Medicines Agency

The Agency’s main roles are the protection of public health, and the evaluation of human and veterinary medicinal products.

EMA in the European Union

• The EMA is the centralized Agency in the European Economic Area (EEA) marketplace and review all Marketing Authorization Application (MAA) going through centralized procedures.
• The EMA also provide Scientific Advices (SA) or Protocol Assistance (PA) on the development of human medicines.
• The EMA is responsible to coordinate the EU’s safety-monitoring Pharmacovigilance (PV) system.
• The EMA provides opinions on all submissions of Orphan Drug Designation (ODD).