EU REGULATORY LANDSCAPE
Across the European Union (EU) the European Commission ensures the quality, safety and efficacy of all human and veterinary medicinal products via a regulatory system which consists of regulations and directives implemented by its member states through competent regulatory authorities.
The European Union (EU) is made up of 28 sovereign member states and has 29 competent authorities, with each member state having its own national regulatory agency.
In addition, the European Medicines Agency (EMA) is the central EU body which co-ordinates the existing resources put at its disposal by member states for the evaluation, supervision and pharmacovigilance of medicinal products.
Iceland, Liechtenstein and Norway are also part of the EU regulatory environment. As members of the European Economic Area (EEA) they are allowed to trade in the single EU market without EU membership, but are required to follow parts of EU law.