EFPIA presents its proposals on the future of EU medicines regulation

The European Federation of Pharmaceutical Industries and Associationshas presented its proposals for the future of the European Union centralized and mutual recognition marketing authorization procedures for the approval of medicines. It held a workshop in Brussels, Belgium, this month at which, said the Federation, all stakeholders and users of the EU marketing authorization procedures were able, for the first time, to present and discuss their views.

EFPIA director general Brian Ager described the "challenging necessity" of building a world-class, scientifically-robust EU regulatory system which would take into account differences in patient, medical and cultural needs within a single market. Progress has been made since 1995, he said, when the two procedures began and the European Medicines Evaluation Agency was established, but the system remains complex, duplicative of EU and national activities and structurally unprepared to meet the challenges of an expanding EU.

The EFPIA says it wants to maintain and improve the two procedures, noting that, overall, it is satisfied with the centralized procedure, which provides the opportunity for a pan-European scientific debate that results in a single decision for the EU in clear timelines. The mutual recognition procedure offers flexibility, it adds, although it could be improved in several ways.