The Italian Medicines Agency makes available a reference document dedicated to the criteria for assessing therapeutic innovativeness and to the modalities for managing anti‑infective agents used in the treatment of infections caused by multidrug‑resistant organisms.
The text provides operational and methodological guidance to ensure a uniform and transparent approach in the assessment of new medicines, with particular attention to therapies aimed at addressing the growing challenge of antimicrobial resistance. The objective is to promote the appropriate and responsible use of antimicrobials, supporting stewardship strategies and enhancing innovative diagnostic and therapeutic tools.
This initiative is part of national and international policies aimed at strengthening patient safety and supporting independent research, contributing to a more effective and sustainable healthcare system.
For further information and to consult the full document, the following link is available: Draft criteria for innovativeness published on 12 March 2025.
