Presentation (CTI)

OBJECTIVES: Ensuring timely access to medicines of significant public health interest is a regulatory priority. The EMA Accelerated Assessment (AA) procedure reduces the CHMP assessment timeline from 210 to 150 days. However, whether this translates into a meaningful time advantage along the access pathway, particularly at national Italian level, remains uncertain. This study assessed AA implementation in reducing Time to Approval (TTA) at EMA level and its impact in Italy on Time to Reimbursement (TTR), Pricing and Reimbursement (P&R) outcomes, and innovativeness.
METHODS: A retrospective analysis was conducted using a proprietary database of 520 medicines authorised through the EMA centralised procedure between October 2017 and December 2025, including only first marketing authorisations. Procedures were classified as standard assessment, AA, or AA converted to standard assessment. TTA (EMA) and TTR (AIFA) were analysed alongside regulatory and access-related variables, including therapeutic area, orphan designation, PRIME status, innovativeness, and reimbursement class. Reasons for conversion from AA to standard assessment were also evaluated.
RESULTS: Overall, 85% of medicines (n=444) underwent standard assessment, including 71 with denied AA requests, while 15% (n=76) entered AA. Among these, 47% (n=36) completed approval through AA, whereas 53% (n=40) were converted to standard assessment. The main reasons for conversion were clinical and manufacturing quality-related concerns (53%). AA was associated with a shorter TTA than standard assessment (230 vs. 456 days; -50%). A favourable, although less pronounced, effect was also observed for TTR (417 vs. 573 days; -27%). Medicines assessed through AA were more frequently granted innovativeness than those approved through standard assessment (50% vs. 23%).
CONCLUSIONS: AA effectively reduces TTA at EMA level and also shows a favourable effect on TTR at the national level. However, frequent conversions indicate that issues emerging during assessment may limit its application, suggesting a gap between the procedure’s potential and real-world use.