On December 20th, 2013 an agreement was reached between the Lithuanian Presidency of the EU and the Parliament on the Clinical Trials Regilation. On April 16, 2014, the new Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adoped. It entered into force on June 16th, 2014 and will apply no earlier than May 28th, 2016.
EU Clinical trials regulation -new legislation
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