Published the 22nd AIFA National Report 2025 on Clinical Trials of Medicinal Products in Italy
The 22nd AIFA National Report 2025 on Clinical Trials of Medicinal Products in Italy provides an updated snapshot of the…
AIFAnews
Drug Negotiation Renewed: Introduction of “Simplified” and “Fast Track” Procedures
The Italian Medicines Agency (AIFA) has recently adopted the new “Document for the Harmonization of Procedures for Simplifying the Price…
Update of the Guidelines for the preparation of the pricing and reimbursement dossier of a medicinal product
With Determination DTS No. 88/2025 of 23 December 2025, AIFA published an update to the ‘Guidelines for the preparation of…
New functionalities activated in the Registry of Observational Studies (RSO)
As of 4 December 2025, the new functionalities implemented in the Registry of Observational Studies (RSO) are active, with the…
AIFA 5% Fund: updated access criteria for orphan drugs and rare diseases
The Italian Medicines Agency (AIFA) has published an update on the access criteria for the AIFA 5% Fund, established by…
Report on AIFA Activities 2024
The Italian Medicines Agency (AIFA) has published the Report on Activities 2024, a document that recounts a particularly intense year,…
AIFA Independent Research Call 2025
The Italian Medicines Agency (AIFA) has published the second call for Independent Research, an initiative aimed at supporting pharmacological interventional…
New composition of the AIFA–Regions Working Table: national coordination on pharmaceutical policies strengthened
The Italian Medicines Agency (AIFA) has updated the composition of the AIFA–Regions Technical Coordination Table, established in January 2025 to…
AIFA reorganisation: HTA for equity of access and sustainability of the healthcare system
The Italian Medicines Agency (AIFA) announces the approval of the new Regulation on the functioning and organisation of personnel, a…
New guidance on Legislative Decree 10/2025: clarifications on the safety characteristics of medicinal product packaging
The Italian Medicines Agency (AIFA) publishes clarifications on the safety features appearing on the packaging of medicinal products. The full…