In brief

On 7 February the decrees of the Ministry of Health aimed at aligning the Italian legislation with Regulation EU 536/2014 on clinical trials were published in the Official Gazette.

Key takeaways

The decrees identify 40 Territorial Ethics Committees (TECs) and, more generally, regulate the functions and composition of Ethics Committees and establish the criteria for the allocation of responsibilities between TECs and National Ethics Committees (NECs). Provided that the functions of TECs and NECs are identical, the above decrees specify that the TECs may also perform, upon request from the relevant clinical sites, functions falling with the competence of NECs’, except for the evaluation of clinical trials and investigations. The decrees also regulate the transitional phase concerning assessment activities of and interactions among the National Coordination Center of Ethics Committees, TECs, NECs, and the Italian Medicine Agency as regards applications for substantial amendments to clinical trials carried out pursuant to Directive 2001/20/EC. Lastly, in order to simplify administrative procedures, the decrees also establish a single fee for clinical trials, which applies throughout the Italian territory.