A new Regulation of the European Parliament and of The Council on Clinical Trials on Medicinal Products for Human Use, directly applies to all individuals in the European Union. It was adopted by the European Parliament (02 April 2014) and by the Council of Ministers (14 April 2014) and signed off on 16 April 2014. It was published in the Official Journal on 27 May 2014 and is expected to become effective on 15 June 2016.