Brussels, 24/06/2013 (Agence Europe) - On 21 June in Luxembourg, the Irish Presidency of the Council of the EU presented health ministers with two progress reports, one focusing on work on clinical trials of medicines for human use and the other on medical devices (for in vitro diagnosis).
On 17 July 2012, the European Commission adopted a draft regulation to boost clinical research in Europe by improving the lengthy and rather opaque authorisation process (see EUROPE 10657). In first reading, a number of points require further work, namely the issues involving: shorter deadlines for authorising and validating clinical trials, ethical evaluations of clinical trials, the protection of volunteers, and payment and a compensation mechanism.
With regard to medical devices and in vitro medical diagnosis instruments, the Council identified two remaining difficulties that it needed to resolve in the discussions on the two draft regulations the Commission presented on 27 September last (see EUROPE 10697). These are procedures for evaluating clinical trials and the method used to improve inspections of evaluation bodies. (IL/transl.fl)