New European Union Clinical Trials Regulation adopted on 14 April 2014

The new European Clinical Trials Regulation (which will replace Directive 2001/20/EC) was adopted in its final version by the Council of Ministers of the EU Member States on 14 April 2014, and published in the Official Journal of the European Union on 27 May 2014. However, the minimum period before it is transposed into the legislation of the 28 Member States has been set at 2 years, during which time it should be possible to publish the decrees of Act No. 2012-300 of 5 March 2012 “concerning research involving the human person” (known as the Jardé Act).

During this (minimum) two-year period, the European Medicines Agency must establish a single online portal to handle all applications for trials submitted by sponsors, together with all the ensuing exchanges between the sponsor, the administrative authorities of States participating in the trial, and the ethics committees of these countries.

The European Medicines Agency must also establish a database where the trials submitted can be seen.

Finally and importantly, the Member States will have 45 days to make a decision on the validity of a clinical trial, in the knowledge that a provision of “tacit agreement” has been adopted, so that in the absence of a response from the authorities within this interval, the trial will be considered accepted.