e-IFU: it is not simply an IFU converted into a PDF
The evolution of the European regulatory framework is opening up new opportunities for the use of electronic Instructions for Use…
Posts by Laura
Adaptation of the Central Database to the European Regulatory Framework
The Decree of 16 June 2026 was published in the Official Gazette, updating the operating procedures of the Central Database…
Update of C(nn) classification for medicinal products authorized through the centralized procedure
Today, the Italian Medicines Agency (AIFA) announced an update concerning the C(nn) classification for medicinal products authorized through the centralized…
OsMed Report 2025: how is pharmaceutical expenditure evolving in Italy?
AIFA has published the new OsMed Report 2025, which provides an updated overview of the use of medicinal products in…
Tavolo Tecnico di Coordinamento AIFA – Regioni: AIFA update
With Determination No. 41 of 28 July 2026, the Technical-Scientific Director of AIFA confirmed the “Tavolo Tecnico di Coordinamento AIFA…
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…
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…
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,…