# Italian Medicines Agency (AIFA)

Source: https://onco.cc/institutions/aifa/  
OnCo record `aifa` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The Italian state agency that authorises medicines nationally, negotiates their price, decides whether the national health service pays for them, and runs the online registries that track who receives the expensive ones.

## Summary

AIFA was created by article 48 of decree-law 269 of 30 September 2003. Since a 2022 reform (decree-law 169 of 8 November 2022) a single Scientific and Economic Medicines Commission (Commissione scientifica ed economica del farmaco, CSE) has taken over the work of the former technical-scientific commission (CTS) and the pricing and reimbursement committee (CPR); its ten members include AIFA's technical-scientific director and the president of the Istituto Superiore di Sanità. The CSE gives the opinion; AIFA's board decides reimbursement and price, and the decision is published in the Gazzetta Ufficiale.

Three instruments are distinctive. First, AIFA's monitoring registries, recognised by law 135 of 2012 as part of the national health service's information system, check that a medicine is prescribed within its reimbursed indication and operate the managed entry agreements negotiated with the company, including payment by result, in which the company repays the cost of patients who do not respond; AIFA's registries page describes a network of about 3,500 health facilities, 32,857 doctors and 2,318 pharmacists. Second, the status of therapeutic innovativeness, assessed on unmet need, added therapeutic benefit and quality of evidence graded with GRADE, gives a specific indication up to 36 months of funding from a national fund for innovative medicines and immediate entry to regional hospital formularies; the criteria were rewritten in 2025 by presidential determination 966/2025 under the 2025 budget law. Third, law 648 of 1996 lets the service pay, on the CSE's opinion, for a medicine authorised abroad but not in Italy, one still in trials, or one used outside its licensed indication, when there is no valid alternative and at least phase 2 evidence.

## Fields

- Kind: Institution
- Last checked: 2026-11-03
- Also known as: Agenzia Italiana del Farmaco; AIFA
- Tags: regulator; hta; reimbursement
- City: Rome, IT
- Type: government
- Website: https://www.aifa.gov.it

## Sources

- AIFA: https://www.aifa.gov.it
- Scientific and Economic Commission (Italian): https://www.aifa.gov.it/commissione-scientifica-economica
- Monitoring registries (Italian): https://www.aifa.gov.it/registri-farmaci-sottoposti-a-monitoraggio
- Innovative medicines (Italian): https://www.aifa.gov.it/farmaci-innovativi
- Law 648/1996 (Italian): https://www.aifa.gov.it/legge-648-96

## Connected records

- institutions: [Alleanza Contro il Cancro (ACC)](https://onco.cc/institutions/alleanza-contro-il-cancro/), [National Centre for Oncological Hadrontherapy (CNAO), Pavia](https://onco.cc/institutions/cnao-pavia/)

---
JSON: https://onco.cc/api/v1/entities/aifa.json