European Hematology Association tentatively responds to the European Commission’s proposal to improve clinical research

Replacing the current Clinical Trials Directive, the European Commission (EC) adopted a proposal yesterday to regulate medical research in Europe. It appears that the Commission has taken to heart many of the criticisms voiced by EHA and other stakeholders and is now proposing to reduce red tape through the introduction of a regulation, rather than a directive. This should simplify the application for market authorization of medicines and ensure procedural coherence of the assessment. In addition, the regulation appears to accommodate multi-national trials with, for instance, a harmonized authorization dossier, and a single submission system.

“Obviously, we must go through the proposal in more detail before we can assess its implications in full” cautions Professor Ulrich Jäger, president of EHA, “but already it appears that the Commission is sensitive to the concerns of medical researchers, that the current directive is hampering clinical - and especially academic – research in Europe.” “EHA will continue to work with the European Parliament and Council to further improve clinical research – in support of the European Hematology community and, most importantly” Professor Jäger adds, “to improve patient care”.