Piloting enhanced co-operation of national competent authorities and ethics committees for a multinational EU drug trial

摘要

Discussions on the proposed EU pharmaceutical Clinical Trials Regulation are entering a hot phase and the assessment of clinical trial applications by competent authorities and ethics committees and the subsequent administrative single decision in each concerned member state are at the center of the debate.While the proposed legislation1 defines the key objectives and steps to be achieved, it leaves detailed processes and the assignment of responsibilities between competent authorities and ethics committees for each member state to decide2. However; to achieve the defined objectives, new ways of co-operation between member states need to be built using experience from the existing voluntary harmonization procedure (VHP) established by the EU Heads of Medicines Agencies.