Update on revision of EU regulation of clinical trials with investigational medicinal products


In July 2012 the European Commission published its proposal for a Regulation replacing Directive 2001/20/EC. Its central feature is the setting up of an EU-wide administrative procedure and portal, based upon mutual recognition of assessments prepared by a reporting Member State, that will allow a single application for the approval of a clinical trial to be conducted in multiple EU Member States. Another key feature is that it will make publication of the results of clinical trials mandatory, regardless of whether a clinical trial is successful or not. The proposed Regulation is expected to apply from some time in 2016. 

The proposed Regulation has been considered by the relevant Parliamentary Committees, which have suggested various amendments for the first reading by the European Parliament in early April 2014. An analysis of the proposed Regulation and the amendments being put forward for the first Parliamentary reading can be found here.