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…
Highlights
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…
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…
EUDAMED: the next deadline is already approaching. Are Manufacturers truly ready?
Starting from 28 May 2026, the Actor, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance modules became mandatory. For many…
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…
PPWR – What changes for companies and how to prepare
On 12 August 2026, one of the first operational deadlines of Regulation (EU) 2025/40 (PPWR) will come into force. For…
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…
From Complaint to Reporting: The New Operational Workflow of the Italian Ministry of Health
With Circular No. 59712 of 21 July 2026, the Italian Ministry of Health introduced a new digital system for managing…
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…
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…
Implantable devices and class III devices: Delegated Regulation (EU) 2026/1451
With the publication of Delegated Regulation (EU) 2026/1451, the European Commission expands the list of implantable devices and class III…
National HTA Medical Device Program (PNHTA‑MD) 2026–2028
Technological innovation must advance hand in hand with sustainability and clinical validation. This Focus examines the National HTA Programme for…
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.…
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…
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…
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…
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…
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 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…
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…
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…
Criteria for the assessment of therapeutic innovativeness and management of anti‑infective agents in infections caused by multidrug‑resistant organisms
The Italian Medicines Agency makes available a reference document dedicated to the criteria for assessing therapeutic innovativeness and to the…
“AIFA establishes the Technical Working Group on Precision Medicine and Prescriptomics
The Italian Medicines Agency (AIFA) has established the Technical Working Group on Precision Medicine and Prescriptomics, with the aim of…