Interim Procedures for Safety Report Submissions Following Ethics Committees Re-organization

Following the ongoing re-organization of ethics committees in Italy, the Italian medicines agency, AIFA, has issued the following advice for developers and marketing authorisation holders:

1. Urgent Safety Measures (USMs) and Development Safety Update Reports (DSURs) must be directed to the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA), which will oversee them until the appropriate CET is identified. However, once the CET becomes operational, these reports must be promptly notified to them. Additionally, the Principal Investigators (PIs) involved in the clinical trial of the USM should be informed without delay.
2. Suspected Unexpected Serious Adverse Reactions (SUSARs) should continue to be submitted to the Competent Authority through Eudravigilance (EV-CTM). If the SUSAR occurred in a clinical trial approved under Directive 2001/20/EC (and not transferred to CTIS), the reporting of SUSARs to the Ethics Committees (ECs) will follow the same procedure until the new CET is identified.

On February 7, 2023, the Ministry of Health (Italy) took a significant step towards implementing the Clinical Trials Regulation by publishing a decree titled "Identification of 40 territorial ethics committees" (LINK in Italian) in the Official Journal. This decree, which was originally dated January 26, 2023, outlines the establishment of 40 ethics committees across different regions. These committees play a crucial role in overseeing and ensuring the ethical aspects of clinical trials, ensuring the safety and well-being of participants involved in medical research.

If the Coordinating Ethics Committee (CEC) has lapsed, certain measures should be considered during the transition phase until the new Territorial Ethics Committees (CET) are established, following the Ministry of Health Decree of 26 January 2023:

The decree took effect on June 7, 2023, with CET (Territorial Ethics Committee) replacing the current CEC (Central Ethics Committee).

On June 7, 2023, AIFA (Italian Medicines Agency) released a practical guide detailing the transition (LINK in Italian). Subsequently, on the 28th of June 2023, AIFA also issued the relevant FAQs (LINK in Italian), outlining the operational procedure for USM, DSUR, and SUSARs notifications.

The file containing the List of CETs is accessible at this link This list is continually updated with the data of the CTEs (Central Ethics Committees) surveyed in OsSC, as well as those functioning in CTIS.