“With the signing of the four decrees on Ethics Committees, a decisive step has been taken, awaited for years, towards the full implementation in our legal system of the European Regulation 536/2014 on clinical trials. This gives a great boost to health research which as well as making it possible to have greater availability of therapeutic alternatives, it constitutes an extraordinary driving force for the socio-economic growth of an important productive sector of our nation”, declared the Minister of Health, Orazio Schillaci.
Specifically, with the Decree of the Minister of Health of 26 January 2023, subject to agreement in the State-Regions Conference, the 40 territorial Ethics Committees are identified which have the task of evaluating the clinical trials on medical devices and medicines for human usealso thanks to the virtuous synergy developed between the Ministry, AIFA, Regions and autonomous Provinces.
Furthermore, with the Decree of the Minister of Health of 27 January 2023, the transitional phase was regulated in relation to the evaluation activities and the methods of interaction between the Coordination Centre, the territorial Ethics Committees, the Ethics Committees of national value and the Italian Medicines Agency.
Another important long-awaited provision, and decisive from the point of view of administrative simplification, is the decree, adopted by the Minister of Health in agreement with the Minister of Economy and Finance, to determine the flat fee for clinical trials.
The regulatory harmonization decree was also signed, which governs, in particular, the functions of the Ethics Committeesthe criteria for the division of responsibilities between local Ethics Committees and National Ethics Committees, the criteria for composition of the Ethics Committees, in order to ensure that the members are in possession of documented knowledge and experience in clinical trials of medicines and medical devices, also in order to guarantee their independence.
“These are measures of fundamental importance for the regulatory approval process of the trials, the result of a shared effort with the Regions and administrations concerned – concludes the Minister – which will have the effect of improving Italy’s performance in the sector, moving in the direction of less bureaucracy without however renouncing that level of scientific rigor which is essential to guarantee safe medicines and medical devices and the overall development of the reference system and industrial fabric”.