Do conditional marketing authorisations actually accelerate patient access? Time-to-access of conditional vs. standard marketing authorisations in Italy, Spain, and Germany

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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

Answers are grounded in this paper and cite their sources.

Conditional marketing authorisations impact patient access in major EU countries, highlighting potential delays in reimbursement.

The EMA's intent to accelerate access to promising medicines may be offset by longer timelines to secure national reimbursement in major EU nations.

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Ardito et al. (2026) studied this question.

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