Italy has published a detailed analysis of medicine pricing and reimbursement timelines under the structure introduced in 2024, when scientific assessment and economic negotiation were brought within a single commission.
The Italian Medicines Agency (*Agenzia Italiana del Farmaco*, AIFA) analysed 1,042 procedures submitted between April 2024 and December 2025 and completed by 31 May 2026. The report measures ten intervals, covering company submission, formal initiation, assessment, Board consideration, signature and legal publication.
Across all procedures, the average interval from formal initiation to completion of the Scientific and Economic Commission (*Commissione scientifica ed economica*, CSE) or Board stage was 125 days. The median was 65 days. The mean from formal initiation to legal publication was 185 days, while the median was 134 days.
The composition of the dataset strongly influenced the aggregate results. Generics, copies and parallel imports represented 56% of completed procedures and averaged 57 days from formal initiation to completion of AIFA’s assessment and negotiation stage. When these procedures were excluded, the mean increased to 209 days. For the same non-generic procedures, the mean interval from formal initiation to legal publication was 273 days.
Longer timelines were recorded for more complex procedures. Orphan medicines averaged 364 days to completion of AIFA’s assessment and negotiation stage and 411 days to legal publication. New chemical and biological entities averaged 261 and 318 days respectively. Only 13 orphan procedures and 38 new-entity procedures were included, limiting the precision of these subgroup estimates.
The analysis includes clock stops while companies provide additional evidence, prepare counterarguments or revise negotiating proposals. It therefore measures total elapsed procedural time rather than time attributable solely to AIFA.
AIFA links the results to the integrated CSE structure. The report provides no like-for-like comparison with the former system, however, and regional procurement and hospital implementation remain outside the measured pathway. The data establish a more detailed baseline for monitoring where time accumulates between submission and national reimbursement taking legal effect.
Source: Italian Medicines Agency, AIFA
Link: Rapporto AIFA: Tempistiche delle procedure di prezzo e rimborso dei farmaci, aprile 2024–dicembre 2025 (AIFA report: timelines for medicine pricing and reimbursement procedures, April 2024–December 2025)
Date: 6 July 2026
