Francesca Spera -

The four decrees on the reorganization of the Ethics Committees, which are a further step towards the full implementation in Italy of the Regulation (EU) no. 536/2014 on clinical trials, have been published in the Official Journal n.31 of 02-02-2023.

The Ministerial Decree of 26 January 2023 identifies the 40 territorial Ethics Committees which have the task of evaluating clinical trials on medical devices and medicines for human use.

Furthermore, the Ministerial Decree of 27 January 2023 regulates the transitional phase in relation to evaluation activities and interactions between the Coordination Centre, the territorial Ethics Committees, the National Ethics Committees and AIFA.

Another important provision has been accomplished with the Ministerial Decree of 30 January 2023, that has led to the determination of the single fee for clinical trials.

Finally, the other Ministerial Decree of 30 January 2023 defines the criteria for the composition and functioning of the territorial Ethics Committees.


RPN will provide any further update and is available to provide full support for any query and for the submission of new Clinical Trial Applications and relevant amendments through the CTIS portal and for the management of ongoing clinical trials in this last transition period.

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