Regulation

In Europe, the EU Regulation No. 536/2014 imposed a profound reorganisation of the evaluation of clinical trials. As of 31 January 2022, it will become fully applicable, with an initial transition period of one year. Within three years, however, the definitive transition to the new provisions will be mandatory for each Member State
(link to the Italian website https://www.aifa.gov.it/regolamento-europeo-sperimentazioni-cliniche).

In Italy, the clinical trials system was the subject in 2018 of Law No. 3 'Delegation to the Government on clinical trials of medicinal products as well as provisions for the reorganisation of health professions and for the health management of the Ministry of Health'.

This Law delegated to the Government, and in particular to the Ministry of Health, the formulation of a series of implementing decrees, providing for the establishment at AIFA of the "National Coordination Centre of Territorial Ethics Committees for clinical trials on medicines for human use and medical devices (CCNCE)"
(link to the Italian website https://www.aifa.gov.it/centro-coordinamento-comitati-etici).

Law No. 3 of 2018 provided for a reduction of local Ethics Committees (ECs) to a maximum number of forty territorial ECs and three ECs of national value, one of which is reserved for trials in paediatric settings.

The Minister of Health's decree of 1 February 2022 identified the following National ethics committees (CEN):

• National ethics committee for paediatric clinical trials, at the Italian Medicines Agency
• National ethics committee for Advanced Medicinal Therapeutical Products (ATMPs), at the Italian Medicines Agency
• National ethics committee for clinical trials of public research organisations (EPR) and other national public organisations, at the Istituto Superiore di Sanità

With the decree of the Minister of Health of 2 March 2022, the members of the "National ethics committee for clinical trials of public research bodies (EPR) and other public bodies of national character (CEN)" established at the Istituto Superiore di Sanità were appointed.