How to get a drug on the EU market

Their know-how is immensely important as the choice of approval procedure in Europe and the selection of the participating authorities can have an impact on the duration and the success of the approval process. The most important procedure is the Centralized Procedure, by which approval is granted for the entire EU as well as Norway and Iceland. This procedure is mandatory for certain types of medicines but may also be chosen on a voluntary basis if certain criteria are met, for instance in the field of innovation.

The centralized application for approval is filed with the London-based European Medicines Agency (EMA). A committee made up of high-level scientific representatives from the national health authorities of all EU Member States scrutinize the application, prepare an assessment report and eventually decide by majority vote whether approval should be granted or not. Based on this recommendation, the European Commission in Brussels then approves the drug for the entire European Union.

The Decentralized Procedure, introduced in 2005, enables companies to submit identical applications simultaneously in several member states. The applicant identifies one national Regulatory Authority as the Reference Member State Authority, who then prepares an interim assessment report and sends it to the other "Concerned Member States". Discussions and arbitration procedures may follow if some member states do not fully agree with the report. This EU wide approval system has developed over time; prior to 2005, a product first had to be approved nationally in one country before identical applications could be filed in other member states.

To make its innovative medicines rapidly accessible across the EU for as many patients as possible,A Decentralized Procedure may take much longer, consequently Some companies prefers this second method for products where the EU does not yet have uniform therapeutic standards and where the choice of the Reference and Concerned Member State could therefore be a decisive factor to achieve Marketing Authorisation.