Francesca Spera -

With the activation of the CTIS on January 31st 2022, Clinical Trials Regulation (EU) no. 536/2014 has officially entered into force, leading to a radical transformation in the management of clinical trials in the European Union (EU) and in the European Economic Area (EEA).

In Italy, while waiting for the finalization of the Ministerial Decrees for the Ethics Committees reorganization and the introduction of a single fee for national adaptation to EU legislation, it is possible to submit through CTIS a partial application, relating only to “Part I” of the dossier.

Part II” can be submitted through the transitional operating procedure which allows the presentation of Part II of the dossier and have full national approval in compliance with the requirements of the Regulation.

For more details you can find the full notice at the following link:

RPN will provide any further update on this hot 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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