The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has reported 323 medicines entering National Health Service reimbursement during 2025, the first full calendar year under the organisational model introduced in 2024.
AIFA authorised 1,021 medicines during the year, compared with 889 in 2024. The number classified for NHS reimbursement rose from 228 to 323, an increase of 42%, substantially faster than the 15% growth in overall authorisations. The comparison nevertheless spans a transition year: the unified Scientific and Economic Committee for Medicines (Commissione scientifica ed economica del farmaco, CSE) only began operating in April 2024 after replacing the separate scientific and price-and-reimbursement committees.
The higher output is consistent with the improvement in throughput reported during the reform. In January 2025, AIFA said the interval from opening a procedure to CSE consideration had fallen from about 262 days in the committee's first three sessions to 136 days in the latest three, approaching President Robert Nisticò's earlier objective of halving access-processing times.
A subsequent analysis covering procedures initiated from April 2024 to December 2025 found a mean of about four months from formal initiation to CSE or Board stage and six to seven months to final publication. Performance remained substantially slower for new chemical and biological entities and orphan medicines than for generics.
The 2025 activity figures therefore add a volume measure to the previously reported timing improvements. They indicate that the reformed structure is completing more reimbursement classifications as well as processing the overall caseload faster, although the remaining delays for complex innovative medicines leave further scope for the simplified and fast-track procedures introduced subsequently.
Source: Italian Medicines Agency
Link: Rapporto sulle attività 2025 (2025 activity report)
Date: 9 September 2026
Source: Italian Medicines Agency
Link: Rapporto sulle attività 2024 (2024 activity report)
Date: 15 October 2025
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 assessment times reduced to four months)
Date: 6 July 2026
