Agenzia Italiana del Farmaco
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Intelligenza Artificiale e salute: le agenzie regolatorie al centro della rivoluzione farmaceutica
Alle sfide poste dall’uso dell’Intelligenza Artificiale è dedicato il dossier AIFA “Intelligenza Artificiale e salute. Come l’IA sta rivoluzionando la ricerca farmaceutica, la medicina di precisione e il futuro della salute globale”.
Mon Mar 09 00:00:00 CET 2026 Information and communication > Press releasesAIFA supports the Rare Disease Day 2026 Highlights News
AIFA headquarters will be illuminated with the colours symbolizing the initiative on February 28 - Rare Disease Day, in order to shine a spotlight on a reality that cannot remain invisible.
Fri Feb 27 00:00:00 CET 2026 Information and communication > Press releasesDuchenne and multiple myeloma: the NHS reimburses two innovative therapies Highlights News
AIFA Board of Directors Approves 6 new medicines (4 for rare diseases) and new indications in oncology.
Thu Feb 26 00:00:00 CET 2026 Information and communication > Press releasesFrom “one-size-fits-all” medicine to tailored treatments Highlights News
AIFA publishes Position Paper on precision medicine and appropriate prescriptions.
Mon Feb 23 00:00:00 CET 2026 Information and communication > Press releasesMemorandum of Understanding between AIFA and NADO (National Anti-Doping Organisation) Highlights News
The Italian Medicines Agency provides NADO with information on doping medicines authorised in Italy, extracted from its database, for the creation of a platform dedicated to athletes.
Mon Feb 09 00:00:00 CET 2026 Information and communication > Press releasesProton Pump Inhibitors (PPIs): AIFA introduces Note ‘N01’ Highlights News
A new Note will regulate the conditions for prescribing Proton Pump Inhibitors (PPIs) covered by the National Health Service.
Tue Feb 03 00:00:00 CET 2026 Information and communication > Press releasesNeglected tropical diseases: defending global health Highlights News
‘Unite, Act and Eliminate’. To join forces, take action and eliminate neglected tropical diseases: this is the call relaunched by the WHO on World Neglected Tropical Diseases Day 2026. AIFA wholeheartedly supports this appeal.
Fri Jan 30 00:00:00 CET 2026 Information and communication > Press releasesAIFA monitoring of pharmaceutical expenditure January-September 2025 Highlights News
Expenditure on medicines dispensed through pharmacies open to the public amounted to €6,425 million (6.33% of the FSN), while expenditure on medicines purchased directly by public healthcare facilities amounted to €11,811 million (11.64% of the FSN).
Thu Jan 29 00:00:00 CET 2026 Information and communication > Press releasesCystic fibrosis: the number of patients eligible for free access to new CFTR modulator medicines has been expanded Highlights News
The Board of Directors' approval covered two orphan drugs, two new molecules, seven generics, three biosimilars and five therapeutic indication extensions.
Wed Jan 28 00:00:00 CET 2026 Information and communication > Press releasesThe first treatment (Skyclarys) for Friedreich's ataxia will be reimbursed by the National Health Service Highlights News
Seven medicines (including three orphan drugs), two generics and six therapeutic indication extensions have been approved for reimbursement by the AIFA Board of Directors.
Fri Dec 19 00:00:00 CET 2025 Information and communication > Press releasesAIFA in Milan: a new era of collaboration between the Agency and the Regions Highlights News
A meeting of the Board of Directors and the conference ‘Pharmaceuticals: the challenges of legislative innovation, research, and sustainability,’ organised in collaboration with the Lombardy Region.
Wed Dec 10 00:00:00 CET 2025 Information and communication > Press releasesAIFA and the Public Prosecutor's Office of Velletri sign a memorandum of understanding to combat gender-based violence Highlights News
A training and awareness-raising conference for staff held at the Agency's headquarters.
Thu Dec 04 00:00:00 CET 2025 Information and communication > Press releasesAntibiotics: ‘If you're not a doctor, don't play doctor.’ The campaign promoted by AIFA in collaboration with the Ministry of Health is underway Highlights News
Advertisements on Rai and Mediaset networks, dissemination in the press, local broadcasters and social media channels.
Mon Dec 01 00:00:00 CET 2025 Information and communication > Press releasesAIFA 2025 call for proposals for independent research on precision medicine and combating antibiotic resistance: over 100 projects submitted Highlights News
Specifically, 32 study proposals concern the fight against superbugs and 75 concern precision medicine.
Fri Nov 28 00:00:00 CET 2025 Information and communication > Press releasesAIFA Ascolta: for an Agency closer to patients’ needs Highlights News
Rules defined for transparent dialogue with associations. The AIFA Incontra project has also been redesigned for other stakeholders.
Fri Nov 21 00:00:00 CET 2025 Information and communication > Press releasesBoard of Directors of 19 November 2025: medicines approved for reimbursement Highlights News
Green light for a generic antiviral and two new indications of a monoclonal antibody.
Thu Nov 20 00:00:00 CET 2025 Information and communication > Press releasesToday is European Antibiotic Awareness Day: European and national data, AIFA’s commitment Highlights News
Stronger and faster action is needed to tackle the global phenomenon of antimicrobial resistance.
Tue Nov 18 00:00:00 CET 2025 Information and communication > Press releasesNational Report on Medicines Use in Italy (OsMed) - year 2024 Highlights News
Stable consumption: almost 2 doses per person per day in 2024. Overall pharmaceutical expenditure has increased (+2.8%), driven by increased public expenditure (+7.7%) in the face of an increasing number of innovative and high-cost therapies reimbursed by the NHS.
Mon Nov 10 00:00:00 CET 2025 Information and communication > Press releasesKaftrio, AIFA committed to quickly concluding the assessment of reimbursement for new indications Highlights News
The Italian Medicines Agency, aware of the importance of treating a serious and complex disease such as cystic fibrosis, is working to ensure that patients have the best treatment options while respecting the sustainability of the National Health Service.
Tue Nov 04 00:00:00 CET 2025 Information and communication > Press releasesAIFA joins 10th anniversary campaign for safer use of medicines Highlights News
Everyone has a role to play in medicines safety. By reporting suspected side effects, you and I can help make medicines safer for everyone,
Mon Nov 03 00:00:00 CET 2025 Information and communication > Press releasesBoard of Directors meeting of October 28, 2025, medicines eligible for reimbursement Highlights News
Two new molecules, one extension of therapeutic indication, one parallel import medicine, one generic medicine, and seven biosimilars.
Wed Oct 29 00:00:00 CET 2025 Information and communication > Press releasesMedicines approved for reimbursement by the AIFA Board of Directors. These include two new molecules, three generics, three biosimilars and an extension of therapeutic indication Highlights News
Green light for the reimbursement of the first subcutaneous treatment for paroxysmal nocturnal haemoglobinuria and the first three biosimilars of denosumab, the monoclonal antibody indicated for osteoporosis and bone loss.
Thu Oct 09 00:00:00 CEST 2025 Information and communication > Press releasesApprovato il nuovo regolamento sul funzionamento dell’Agenzia Highlights News
L’AIFA si riorganizza e punta sull’HTA per garantire la sostenibilità economica del sistema.
Tue Oct 07 00:00:00 CEST 2025 Information and communication > Press releasesUse of paracetamol during pregnancy: European recommendations confirmed Highlights News
The Italian Medicines Agency (AIFA) reports that, in light of the latest scientific assessments carried out at European level, there is no new evidence requiring changes to the current recommendations.
Tue Sep 23 00:00:00 CEST 2025 Information and communication > Press releasesAIFA monitoring of pharmaceutical expenditure January-April 2025 Highlights News
Spending on medicines purchased directly by the Regions slows down.
Mon Sep 22 00:00:00 CEST 2025 Information and communication > Press releases