Insights

The Italian Medicines Agency (AIFA) has released the Version 2.0 (November 2025) of its Questions & Answers document concerning the implementation of EU Regulation No. 536/2014 on Clinical Trials. This edition consolidates and updates several critical operational and regulatory aspects for sponsors, Ethics Committees (ECs), and stakeholders.

🔴 Key updates and additions include:

1. CTIS Access (Updated): Clarifies the responsibilities of clinical centers and ECs in maintaining updated data in OMS, and outlines conditions for CTIS access and role validation.

2. Safety Reporting (Updated/New)

• ASRs must be submitted via CTIS; direct submission to ECs is no longer required.
• SUSAR notifications remain through EudraVigilance; safety data must still reach investigators.
• Safety alerts (USM, Unexpected Events) must be notified via CTIS.
• New clarification confirms that ASR obligations start from the date of authorization, even if the trial has not begun.

3. Medical Devices & IVDs (New)

• New guidance on combined drug-device studies and IVDs used outside their CE mark or intended use.
• Regulatory path depends on the primary function (drug or device), with implications for CTIS and national submissions.

4. Radiopharmaceutical Clinical Trials (New)

• Detailed requirements for protocol content, dosimetry, and ethical evaluation aligning with Euratom and ICRP standards.
• ECs must reflect their evaluation in the Part II assessment report.

5. Non-Commercial Trials & EC Responsibilities (New)

• Sponsors receiving private funding must provide contracts for ethical review.
• ECs are now always required to upload the Part II assessment report in CTIS, or the process proceeds with conditions.

RPN will provide any further update and is available to provide full support for clinical trial activities.