OBJECTIVES: Early access to innovative medications is a key factor for the quality of medical care. We investigated differences in approval dates of new active substances between the United States (US) and Europe.

METHODS: Data of new active substances approved by the US FDA and EMA from 01.01.2018–26.05.2023 were retrieved from FDA and EMA websites. Generic, biosimilar and hybrid approvals were excluded from evaluation. We reviewed whether and when each drug was approved by the other agency. Subsequently, the time difference between the drug approval dates between the agencies was calculated.

RESULTS: In total, n = 353 new active substances were approved since 2018 by FDA or EMA. Of these, 101 (28.6%) were only approved by FDA compared to 31 (8.8%) only by EMA. From the 221 active substances approved by both agencies, 70 (31.7%) were approved with 0.5 years difference. 85 (38.5%) substances were approved by FDA 0.5–1.5 years earlier, 33 (14.9%) 1.5–3 years earlier and 10 (4.5%) >3 years earlier. On the other hand, 7 (3.2%) substances were approved by EMA 0.5–1.5 years earlier, 5 (2.3%) 1.5–3 years earlier and 11 (5.0%) >3 years earlier. Therefore, US patients on average get access to innovative medicines earlier than European patients.

CONCLUSIONS: More than 25% of new active substances approved by the FDA within the last five years are not yet approved in Europe whereas only less than 10% of new active substances approved by EMA are not yet approved by FDA. In total these results lead to later access to innovative medicines in Europe than in the US. Potential reasons for this may be strategic market and pricing decisions of the pharmaceutical industry or differences in data information, evaluation criteria and timelines between the two jurisdictions.