The new 2024 Activity Report of the Italian Medicines Agency (AIFA) has been published, confirming the strategic role of clinical research in Italy and the continuous evolution of inspection and oversight activities, ensuring the quality and ethical standards of clinical trials.

The report pays particular attention to clinical trials managed through the Clinical Trial Information System (CTIS), the European portal that centralizes authorization and monitoring procedures. AIFA proudly reports the successful completion of the transition to this system. In 2024, over 4,500 clinical trials and more than 2,400 substantial amendments were registered within CTIS.

Furthermore, AIFA highlights the completion of the alignment with European regulations, marked by the submission of the final amendment under Legislative Decree 211/2003 in November 2024. These figures reflect the vitality of the sector and the national system’s ability to integrate Italian research centers — including pediatric ones — into the broader European clinical research landscape.

The report also dedicates significant space to inspection activities related to Good Clinical Practice (GCP), which in 2024 included:

• 21 national trial centers
• 6 EMA-mandated inspections, an increase compared to 2023
• 9 Phase I units and 11 Ethics Committees

Beyond oversight, AIFA emphasizes the educational dimension of these activities, promoting opportunities for dialogue and training, such as the 2024 GCP Symposium held in Rome, with participation from institutional representatives, sponsors, and research groups.

For the INCiPiT Consortium, which promotes high-quality pediatric clinical trials, the data from the AIFA 2024 Report are a positive signal.

The growth in clinical trials, the strengthening of GCP practices, and the increasingly close collaboration between AIFA, EMA, and national centers provide fertile ground for the development of innovative, safe, and ethical studies — to the benefit of younger patients.

📄 Source: AIFA 2024 Activity Report, pp. 88–90
🔗 Read the full report on the AIFA website: AIFA 2024 Activity Report