The 2025 Activity Report of the Italian Medicines Agency (AIFA) is now available, providing an overview of the Agency’s evolution and the main activities carried out during a year focused on consolidating its organisational reform.
A year marked by a strong focus on access to innovation, sustainability, process efficiency and digitalisation.
Some key figures highlight the scale of AIFA’s activities:
💊 323 medicines reimbursed and 1,021 medicines authorised;
💶 62 price and reimbursement renegotiation procedures concluded in 2025, with the aim of optimising pharmaceutical expenditure and ensuring access to innovative medicines;
⏱️ a reduction in the time required for the negotiation process, with an average of approximately 4 months from the start of the negotiation procedure to its conclusion by the CSE, while the overall average time to publication in the Official Gazette stood at 6–7 months;
🔬 € 37.8 million allocated to independent research, through calls covering, among others, rare diseases, antimicrobial resistance and precision medicine;
🧪 301 initial clinical trial applications assessed and 185 inspections conducted.
Particularly noteworthy is also Italy’s continued integration into the new European Health Technology Assessment (HTA) system, alongside the update of the criteria for the classification of innovative medicines and anti-infective agents for infections caused by multidrug-resistant pathogens, within the framework of the dedicated special funds.
On the digital transformation front, 2025 saw the completion of the migration of AIFA’s data and services to the National Strategic Hub (Polo Strategico Nazionale), alongside the integration of Artificial Intelligence tools to support the optimisation of internal processes.
The Report also offers a broader reflection on the role of the Agency. As highlighted by AIFA President Robert Giovanni Nisticò, “AIFA is called upon to make decisions on complex issues and, often, to manage uncertainty, without ever losing sight of the public interest and the protection of patients.”
It is precisely this balance between timely access, appropriateness, the value of innovation and the sustainability of the Italian National Health Service (SSN) that will remain one of the key challenges for pharmaceutical governance in the years ahead.
📄 The 2025 Activity Report is available on the AIFA website.
