IS EUROPE BECOMING A LATER REGULATORY LAUNCH MARKET? TRENDS IN EMA AUTHORISATION AFTER FDA APPROVAL
Author(s)
Sofia Gomes, PharmD1, Georgia Plexida, PharmD2, Matthew Wallace, MPharm, MPH3.
1Fortrea, Oeiras, Portugal, 2Fortrea, Athens, Greece, 3Fortrea, Leeds, United Kingdom.
1Fortrea, Oeiras, Portugal, 2Fortrea, Athens, Greece, 3Fortrea, Leeds, United Kingdom.
OBJECTIVES: Europe faces intensifying pricing and policy pressures, raising concern that medicine manufacturers may delay or deprioritise European market entry. This study examined whether the time to European Medicines Agency (EMA) authorisation following US Food and Drug Administration (FDA) approval has changed over the past decade.
METHODS: Using publicly available FDA and EMA data, we analysed medicines approved by the FDA from January 2014 to December 2023, with EMA follow-up to December 2025. Medicines with EMA authorisation before FDA approval were excluded. Kaplan-Meier analysis estimated the cumulative probability of EMA authorisation within 24 months of FDA approval, censoring medicines without EMA authorisation by December 2025. A 24-month window was selected to reflect a commercially meaningful and policy-relevant timeframe for first major-market regulatory entry. Two period cohorts (2014-2018 and 2019-2023) were compared to contrast an earlier baseline with a more recent period characterised by evolving European policy and access pressures, including the post-COVID launch environment.
RESULTS: Among 456 FDA-approved medicines, 72 (15.8%) received EMA authorisation before FDA approval and were excluded (2014-2018: 17.4%, 2019-2023: 14.4%; p=0.386). Among the remaining 384 medicines, 229 received EMA authorisation by December 2025, including 210 within 24 months. The Kaplan-Meier estimated probability of EMA authorisation within 24 months was significantly lower for the 2019-2023 cohort than for the 2014-2018 cohort (46.2% vs 64.8%; log-rank p<0.001).
CONCLUSIONS: FDA-approved medicines were less likely to receive EMA authorisation within 24 months during 2019-2023 than during 2014-2018. Findings suggest recent slowing in the timing of EMA authorisation following FDA approval, consistent with, but not definitive evidence of, a possible shift in global launch sequencing against a backdrop of evolving European pricing and policy pressures. Results should be interpreted as directional indicators of launch dynamics, not as causal evidence of reduced European market attractiveness.
METHODS: Using publicly available FDA and EMA data, we analysed medicines approved by the FDA from January 2014 to December 2023, with EMA follow-up to December 2025. Medicines with EMA authorisation before FDA approval were excluded. Kaplan-Meier analysis estimated the cumulative probability of EMA authorisation within 24 months of FDA approval, censoring medicines without EMA authorisation by December 2025. A 24-month window was selected to reflect a commercially meaningful and policy-relevant timeframe for first major-market regulatory entry. Two period cohorts (2014-2018 and 2019-2023) were compared to contrast an earlier baseline with a more recent period characterised by evolving European policy and access pressures, including the post-COVID launch environment.
RESULTS: Among 456 FDA-approved medicines, 72 (15.8%) received EMA authorisation before FDA approval and were excluded (2014-2018: 17.4%, 2019-2023: 14.4%; p=0.386). Among the remaining 384 medicines, 229 received EMA authorisation by December 2025, including 210 within 24 months. The Kaplan-Meier estimated probability of EMA authorisation within 24 months was significantly lower for the 2019-2023 cohort than for the 2014-2018 cohort (46.2% vs 64.8%; log-rank p<0.001).
CONCLUSIONS: FDA-approved medicines were less likely to receive EMA authorisation within 24 months during 2019-2023 than during 2014-2018. Findings suggest recent slowing in the timing of EMA authorisation following FDA approval, consistent with, but not definitive evidence of, a possible shift in global launch sequencing against a backdrop of evolving European pricing and policy pressures. Results should be interpreted as directional indicators of launch dynamics, not as causal evidence of reduced European market attractiveness.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR217
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
No Additional Disease & Conditions/Specialized Treatment Areas