The ecosystem of medical device development: the strategic role of Early Feasibility Studies (EFS)
Within the complex and dynamic ecosystem of medical device development, innovation cannot advance without a solid and timely clinical strategy.…
Focus
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…
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…
New criteria for the classification of innovative medicines and anti‑infective agents
With the publication of AIFA Determination No. 966/2025, new criteria are introduced for the classification of innovative medicines and anti‑infective…