The European Union Regulation 536/2014 on clinical trials on medicinal products for human use (so called Clinical Trials Regulation - CTR)has been approved by the Council of the European Union and therefore published on the Official Journal of the EU in April 2014. This marks the end of the legislative iter of the Regulation, which intent to modify the existing 2001 Directive on Clinical Trials, which regulated the way clinical trials are held in Europe; it was responsible for the dramatic drop of trials held in Europeby 25%.

ECPC hopes that the approval of this new regulation will facilitate the set up of international clinical trials, which is fundamental for the development of new, effective treatments against cancers, particularly those considerate as rare.

The current regulation will enter into force in May 2016.

Q&A on the CTR

General information on clinical trials from the European Commission