EU REGULATION N. 536/2014
The evaluation system of clinical trials in Europe faces a radical change starting from 31 January 2022, with the full application of Regulation (EU) n. 536/2014.
From that date, a one-year transition period began, during which applications for clinical trial authorization can still be submitted on a voluntary basis pursuant to Directive 2001/20/EC, which will not, however, be applicable, together with the relevant national regulations, for all other new trials. Within three years there will be the definitive transition to the provisions of the Regulation for all trials in progress.
With the application of the Regulation, the European Union pursues the aim of promoting the efficiency of clinical trials, especially in the case of trials carried out in several Member States, while stimulating innovation and research and limiting duplication of assessments and repetitions of experiments without added value.
The European Regulation was therefore born with the aim of creating a favorable environment for the conduct of clinical trials in Europe, through the harmonization of the rules and processes of evaluation and supervision of the same, while guaranteeing the highest standards for the safety of the participants and transparency of information, thanks to the related publication of all information regarding the authorisation, conduct and results of each trial conducted in Europe.
With regard to this last point and in order to improve the transparency of information on clinical trials, a dedicated portal for the management of all trials in Europe (Clinical Trials Information System, CTIS) has been developed, which will be essential for transparency and for enable the strengthening of collaboration, exchange of information and decision-making processes between and within Member States.
The authorization and supervision of clinical trials will remain under the responsibility of the Member States, while the EMA will manage the CTIS and the publication of its contents in the public section of the portal.
