Clinical Trials Regulation adopted by EU Council of Ministers

On April 14th, the Council of Ministers, representing the governments of member states of the European Union, formally approved a draft regulation aimed at facilitating and speeding up the authorisation procedure of clinical trials, following its agreement by the European Parliament in earlier in April.

This means that the regulation is now adopted. It will enter into force 20 days following its publication in the Official Journal of the European Union and apply six months after a EU portal for the submission of data on clinical trials and a EU database identifying each clinical trial have become fully functional (but not earlier than two years after the regulation’s publication).

The Regulation is expected to be published in the Official Journal early in May. This will begin an adoption/transition period that will last for just over over 5 years.