Francesca Spera -

The clinical trials evaluation system in Europe will face a radical change starting from January 31st, 2022, with the full application of Regulation (EU) no. 536/2014.

With this Regulation, the European Union aims to promote the clinical trials efficiency, especially in the case of trials carried out in several Member States, while stimulating innovation and limiting duplication of evaluation and repetition of clinical trials without added value.

The dedicated portal for the management of all trials in Europe (Clinical Trials Information System, CTIS) will be fundamental for transparency and to strengthen collaboration, information exchange and decision-making processes between Member States and within them.

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 release of its contents in the public section of the portal.

To be ready for the entry into force of the Clinical Trials Regulation (EU) No 536/2014 and the go-live date for CTIS, RPN will provide any further update on this topic and is available to provide full support for any query and for the submission of Clinical Trial Applications and relevant amendments.


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