EU Agencies Update

Responsibility for pharmaceuticals in the European Union is divided between the governments of the 27 member states* and the EU's institutions. The principal EU bodies concerned are the European Commission in Brussels and the European Medicines Agency in London. However, the decision making process also involves other EU institutions—including notably the European Parliament and the EU Council of Ministers.

The Commission department most directly involved, the Pharmaceuticals Unit in the Directorate General for Enterprise, is tasked with developing and maintaining a favorable environment for medicinal products in the EU. At the same time it is responsible for ensuring a high level of protection of public health, helping to create a single EU market in pharmaceuticals, and fostering a stable and predictable environment for pharmaceutical innovation.

In terms of regulation, it is the Commission that maintains, updates, and simplifies EU pharmaceutical legislation, and that formally grants marketing authorizations for the EU market. It supports the member states in the mutual recognition and decentralized authorization procedures and in operating national mutual authorizations. And it provides guidance on pharmaceutical legislation and ensures that it is properly implemented within the EU.