Italy has published its first detailed post-reform analysis of price-and-reimbursement timelines, giving a granular view of national processing under the unified committee structure introduced in April 2024.
The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) published Price and reimbursement procedure timelines April 2024–December 2025 (Tempistiche delle procedure di prezzo e rimborso dei farmaci aprile 2024–dicembre 2025) on 6 July. It analysed 1,042 completed procedures from 1,461 submissions.
Across all procedures, the mean from formal initiation to the Scientific and Economic Committee for Medicines (Commissione scientifica ed economica del farmaco, CSE) or Board stage was 125 days; the median was 65 days. Generics, copies and parallel imports represented 56% of completed procedures and averaged 57 days. Excluding them, the mean rose to 209 days, and to 273 days from initiation to legal publication.
More complex procedures took longer. Only 13 orphan and 38 new-entity procedures were included, limiting the precision of these estimates. However, orphan medicines averaged 364 days to the CSE or Board stage and 411 days to publication. New chemical and biological entities averaged 261 and 318 days respectively.
The latest European Federation of Pharmaceutical Industries and Associations, EFPIA, Patients W.A.I.T. Indicator placed Italy third for availability, at 79%, and reported a median 393 days from EU authorisation to reimbursement listing. These figures are consistent with those for AIFA’s closest subgroup, new chemical and biological entities, in which the median was 371 days from company submission to publication and 309 days from formal initiation of the pricing and reimbursement process to publication.
AIFA says CSE integration, prioritisation, removed steps and digital publication have improved performance. More recent simplified and fast-track routes may reduce approval times further in later cohorts.
Source: Italian Medicines Agency
Link: AIFA pubblica il Rapporto sulle tempistiche di prezzo e rimborso 2024-2026: tempi medi di valutazione ridotti a 4 mesi (AIFA publishes report on price and reimbursement timelines 2024–2026: average evaluation times reduced to four months)
Date: 6 July 2026
Source: European Federation of Pharmaceutical Industries and Associations
Link: EFPIA Patients W.A.I.T. Indicator 2025 Survey
Date: 19 May 2026
