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…
News
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…
EMA publishes the Report on the EU Drug Repurposing Pilot Project
The European Medicines Agency (EMA), together with the national regulatory authorities of the European Union, has made available the final…
Horizon Scanning 2025: overview of new medicines and innovative therapies
The Italian Medicines Agency (AIFA) has made available the 2025 edition of the Report ‘Horizon Scanning: scenario of upcoming medicinal…
Workplan 2025–2028 of the Joint HMA/EMA Network Data Steering Group: data and artificial intelligence for the regulation of medicinal products
The Joint HMA/EMA Network Data Steering Group (NDSG) has published the new 2025–2028 Workplan, marking a key milestone in the…