- 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).