AIFA published its 2025 Activity Report
The 2025 Activity Report of the Italian Medicines Agency (AIFA) is now available, providing an overview of the Agency’s evolution…
AIFA
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…
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 Price and Reimbursement Dossier for a Medicinal Product
Following the publication of the Regulation governing the organization and functioning of the Scientific and Economic Commission (CSE), adopted by…
Dialogue with the CSE: modalities and procedures for hearings
AIFA has published the procedures for requesting a hearing before the Scientific and Economic Commission for Medicines (CSE). Companies, scientific…
Pharmaceutical sector in evolution: objectives of the Consolidated Act
The main objectives of the measure are to improve access to medicines, optimise the regulatory framework governing the provision of…