1. Executive Summary

This workbook provides an overview of the current and proposed regulatory landscape applicable in Italy in relation to Decentralized Clinical Trials (“DCT”). It supplements the regulations applicable to the EU and EEA described in the European Medicines Agency (“EMA”) workbook. The directives of the Clinical Trials Regulation (EU) No 536/2014 (“EU CTR”), which came into effect in January 2022, are implemented in individual countries through national legislation.  

In Italy, the EU Clinical Trial Regulation 536/2014 is being implemented at the national level through different laws and decrees:

• Law No.3 of 11 Jan 2018 (also known as the “Legge Lorezin”). Delegation to the Government on clinical trials of medicines as well as provisions for the reorganization of health professions and for the health management of the Ministry of Health.
• Law No52 of 14 May 2019 - Implementation of the delegation for the reorganization and reform of legislation clinical trials of medicinal products for human use, Pursuant to Article 1, paragraphs 1 and 2, of Law 11 January 2018, n. 3. 
• MoH Decree 26 Jan 2023 - Identification of forty territorial Ethics Committees.
• MoH Decree  27 Jan 2023 - Regulation of the transitional phase pursuant to Art 2, paragraph 15, of Law No.3 of January 11, 2018, on the evaluation activities and the methods of interaction between the Coordination Centre, the territorial ethics committees, the ethics committees of national significance, and the Italian Medicine Agency (AIFA).
• MoH Decree of 30 Jan 2023 - Definition of the criteria for the composition and operation of territorial ethics committees.
• MoH Decree of 30 Jan 2023 - Determination of the single fee for clinical trials.