Do conditional marketing authorisations actually accelerate patient access? Time-to-access of conditional vs. standard marketing authorisations in Italy, Spain, and Germany | Synapse
April 17, 2026Open Access
Do conditional marketing authorisations actually accelerate patient access? Time-to-access of conditional vs. standard marketing authorisations in Italy, Spain, and Germany
Key Points
To evaluate whether conditional marketing authorisations lead to faster patient access compared to standard approvals.
Comparison of timelines for access to medicines under conditional and standard authorisations
Focus on three major EU countries: Italy, Spain, and Germany
Analysis of national reimbursement processes
Conditional marketing authorisations do not consistently lead to shorter access times compared to standard authorisations
Delays in securing national reimbursement offset intended benefits of faster access
Considerable variation in timelines exists among the three countries studied
Abstract
The EMA's intent to accelerate access to promising medicines may be offset by longer timelines to secure national reimbursement in major EU nations.