AIFA (Italian Medicines Agency)

Updated model for reimbursement of expenses and compensation for trial participants

CCNCE publishes version 4 (16 September 2026) of the model template for reimbursing trial participant expenses and compensation.

AIFA in the National Digital Data Platform

AIFA's medicines information assets are now accessible through Italy's National Digital Data Platform as part of public health digital transformation.

AIFA online services: activation of multi-factor authentication (MFA) from 19 October 2026

AIFA introduces multi-factor authentication (MFA) as an additional secure access method to its online services alongside existing methods.

IncreaseNET Project: two training courses launched for regulatory agency experts

AIFA launches training courses on Organ-on-Chip and RNA Therapeutics for regulatory experts.

From 19 October 2026: new access methods for AIFA online services

Rare diseases: Europe in dialogue on innovation and therapy access

A Roma i lavori del Committee for Orphan Medicinal Products (COMP) dell’EMA. Al centro del confronto ricerca, regolamentazione e accesso alle terapie per le malattie rare.

Monoclonal antibodies for Alzheimer's: AIFA meets with manufacturers

AIFA announced willingness to define clinical practice monitoring models to generate new evidence on monoclonal antibodies for Alzheimer's disease.

AIFA in Genoa: the value of pharmaceutical innovation at the centre of discussion with regions

Si è svolto a Genova, presso il Palazzo Ducale, il convegno “Misurare il valore dell’innovazione - Dalla valutazione del farmaco agli esiti di salute”, organizzato dall'Agenzia Italiana del Farmaco (AIFA) con il patro...

AIFA Scientific and Economic Commission (CSE): meeting agenda, 12–16 October 2026

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 12-16 ottobre 2026.

Notification of measures – GMP Medicines Inspections and Authorisations Office

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

AIFA in Genoa: October 16 discussion on the value of pharmaceutical innovation

L’incontro “Misurare il valore dell’innovazione - Dalla valutazione del farmaco agli esiti di salute”, promosso dall’Agenzia Italiana del Farmaco venerdì 16 ottobre, a partire dalle 9.30, nella Sala del Maggior Consig...

Notification of measures – GMP Medicines Inspections and Authorisations Office

Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).

AIFA Transparency Log Update

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 16/10/2026.

Types of proceedings - section update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tipologie di procedimenti".

AIFA updates transparency lists for generic medicines

AIFA publishes updated reference prices for generic medicines effective 15 October 2026.

AIFA: Supplementary negotiation section update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Contrattazione integrativa".

Types of proceedings - section update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tipologie di procedimenti".

AIFA: Grants and Authorisations Section Update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Atti di concessione".

Types of proceedings - section update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tipologie di procedimenti".

Types of proceedings - section update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tipologie di procedimenti".

Types of proceedings - section update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Tipologie di procedimenti".

AIFA Transparency Log Update

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 09/10/2026.

AIFA Transparency Log Update

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 02/10/2026.

Drug shortages and therapeutic continuity: AIFA new dossier online

AIFA publishes guidance on ensuring patient care continuity when medicines are unavailable in pharmacies.

Tables of Class A and H medicines as of 31 May 2026

AIFA publishes lists of Class A and H medicines dispensed by the Italian National Health Service, ordered by active ingredient and brand name.

AIFA Transparency Log Update

L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 25/09/2026.

Pharmaceutical expenditure January–February 2026: AIFA final monitoring

Total public pharmaceutical expenditure in Italy for January–February 2026 reached €4,529.7 million.

Review of the National Pharmaceutical Formulary

AIFA's Board has adopted the Ministry of Health's strategic directive on revision of the national pharmaceutical formulary.

AIFA: Update of section on holders of political, administrative, management and governance positions

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

AIFA Online Services: Extraordinary Maintenance

AIFA online services will be unavailable from 16 October 2026 14:00 to 19 October 2026 10:00.

AIFA: Update of section on holders of political, administrative, management and governance positions

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Titolari di incarichi politici, di amministrazione, di direzione o di governo".

Closure of PEC mailbox for the Medicines Information and Advertising Surveillance Office (UIMVP)

New operational procedures for correspondence to the Medicines Information and Advertising Surveillance Office, previously handled via PEC.

AIFA: Update to management personnel and general acts section

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Ruolo dirigenti e Atti generali".

AIFA Financial Statements - section update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Bilanci AIFA".

AIFA: Updates to governance decisions section

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Provvedimenti organi indirizzo-politico".

Available management positions - section update

L'Agenzia Italiana del Farmaco, ai sensi del d.lgs. 33/2013, rende disponibili aggiornamenti della sezione "Posti di funzione disponibili".

AIFA: Notice for appointment to senior management position, Office of Economic Evaluations

Avviso per il conferimento del posto di funzione dirigenziale di livello non generale di direzione di struttura complessa (Ufficio valutazioni cliniche)

Promoting clinical research culture in general medicine: AIFA and FIMMG launch new e-learning course

AIFA and FIMMG launch an e-learning course to equip general practitioners with methodological tools to understand, evaluate and participate in clinical research.

Active pharmacovigilance: AIFA call for a national project dedicated to elderly, multimorbid and polypharmacy patients

AIFA announces funding of €10.5 million for a national active pharmacovigilance project targeting elderly patients with multiple chronic conditions on multiple medications.

Antimicrobial resistance: the One Health approach – COSIsiFA project e-learning course launched

AIFA has launched a new e-learning course on antimicrobial resistance and One Health approach under its independent scientific information on medicines programme.

Joint notice by AIFA, AssoFarm, FarmacieUnite and Federfarma to promote direct ordering in pharmacies

AIFA and pharmacy associations issue guidance on direct ordering as a tool to ensure treatment continuity when distribution supply chains are disrupted.

QALSODY (tofersen) activation in monitoring register and reimbursement publication

QALSODY (tofersen) approved for reimbursement by the Italian National Health Service from 22 September 2026 for a specific therapeutic indication.

AIFA Board approves reimbursability for one new orphan drug, six indication extensions including paediatric use, and three generics

AIFA approved reimbursement for a new orphan medicine, six indication extensions in oncology, HIV-1 infection and adolescent mental health, and three generic medicines.

AIFA Board approves reimbursement for 2 new orphan medicines and 7 indication extensions

AIFA approved reimbursement for two orphan drugs for plexiform neurofibromas in neurofibromatosis type 1 and biliary tract cancer, plus seven indication extensions.

Important Safety Information Notice (NIIS) on Ocrevus (ocrelizumab)

New risk of drug-induced liver damage identified; hepatic function monitoring recommended before and during treatment.

Update to EVRYSDI monitoring register

The monitoring register for EVRYSDI (risdiplam) has been updated as of 30 September 2026 for a specific therapeutic indication.

Tecentriq monitoring registers updated

Monitoring registers for Tecentriq have been updated as of 22 September 2026 for specified therapeutic indications.

Update to Brukinsa monitoring registers

Monitoring registers for Brukinsa have been updated as of 22 September 2026 for specific therapeutic indications.

OPDIVO first-line urothelial carcinoma: registry update

The OPDIVO first-line registry for urothelial carcinoma has been updated as of 23 September.