Italy has revised AIFA’s 2026 activity programme following requests from the Regions for greater involvement in national medicines governance. The programme was originally approved in December 2025 and updated in January. The Board adopted the latest revision on 29 July before sending it to the State-Regions Conference for its required opinion.
The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) retains the review of the National Pharmaceutical Formulary (Prontuario Farmaceutico Nazionale, PFN) among its 2026 priorities. This continues AIFA’s existing work to reassess reimbursement status and conditions and, where appropriate, renegotiate medicines. Guiding principles and therapeutic areas for the current review have been agreed with the supervising ministries, and preliminary work has started within the Scientific and Economic Committee for Medicines (Commissione scientifica ed economica del farmaco, CSE).
The clearer change concerns coordination with the Regions. AIFA will develop arrangements for sharing HTA documentation through its technical coordination table, subject to confidentiality. It also envisages jointly defined objectives and indicators covering reimbursement, appropriate prescribing, generic and biosimilar use and economic impact.
EU HTA receives greater prominence. AIFA plans continued participation in joint clinical assessments and joint scientific consultations and further adaptation of national assessment and price-and-reimbursement work to the EU framework.
Existing delivery targets also remain. AIFA aims to start CSE assessment for 90% of new-medicine P&R applications submitted during the first eight months of 2026 and to complete 80% of the project replacing its monitoring-register platform. Scientific advice and pre-submission procedures are also due to develop further.
The July revision therefore mainly strengthens the links between national assessment and regional implementation. It gives regional engagement and EU HTA a more explicit place in AIFA’s remaining 2026 work, while the PFN review continues established national formulary-management activity.
Source: Italian Medicines Agency
Link: Programma di attività per l’anno 2026 dell’Agenzia Italiana del Farmaco (Italian Medicines Agency Activity Programme for 2026)
Date: 29 July 2026
Source: Sanità33
Link: Aifa aggiorna il Programma 2026. Più spazio a Hta, IA e gestione delle carenze (AIFA updates its 2026 programme. Greater focus on HTA, AI and shortage management)
Date: 6 August 2026
Source: Quotidiano Sanità
Link: Aifa. Rivisto il Programma attività 2026 dopo le richieste delle Regioni. Dalla revisione del prontuario alla governance, ecco le novità (AIFA. 2026 activity programme revised following requests from the Regions. From formulary review to governance, the changes)
Date: 6 August 2026
