Spain reduces drug approval time by 70 days, report finds

The Spanish Ministry of Health has published its third report on the financing of innovative medicines, confirming a 70-day reduction in the total access time from European authorization to public funding. The median access time now stands at 474 days, down from 544 days in the first analysis of 2025. Source: infobae

What the report shows

The report analyzes 221 innovative drugs authorized in the EU between 2021 and 2024. Of these, 187 (84.6%) are registered in Spain, and 143 (76.5%) have obtained public funding. The overall funding rate across all EU-authorized drugs is 64.7%. Source: elconfidencial

• The improvement is attributed to a faster national phase: the time from registration in Spain to a funding decision dropped to 400 days (median), compared to 431 days initially. Source: infobae
• The administrative registration step after EU authorization remains stable at 43 days (median). Source: infobae
• A notable 15.4% of funded drugs went through multiple negotiation rounds (successive files), with 80.8% of those exceeding one year ultimately receiving positive funding. Source: elconfidencial

Access mechanisms

Spain's early access pathway, Medicamentos en Situaciones Especiales (MSE), has enabled access to 55.2% of authorized drugs, particularly crucial for rare diseases: 36.8% of drugs using this route were orphan drugs. Source: infobae The Ministry notes that while these treatments often involve complex negotiations, the mechanism ensures availability during the administrative process.