OBJECTIVES: A key factor for quality of medical care is early access to innovative pharmaceuticals. We investigated differences in approval dates of new active substances (NAS) between Europe, Japan, and the United States.

METHODS: Data of NAS approved by EMA, PMDA and FDA from 01.01.2018–31.01.2024 were retrieved from the respective websites. Generic, biosimilar and hybrid approvals were excluded. We reviewed whether and when each product was approved by the other agencies. Subsequently, we calculated time differences between drug approval dates between the agencies.

RESULTS: In total, n = 516 NAS were approved since 2018 by EMA, PMDA and/or FDA. Of these, EMA approved 332, PMDA approved 271, and FDA approved 402. Of the 516, 169 (32.8%) were approved by all EMA, PMDA and FDA, 20 (3.9%) by EMA and PMDA only, 114 (22.1%) by EMA and FDA only, 17 (3.3%) by PMDA and FDA only, 29 (5.6%) by EMA only, 65 (12.6%) by PMDA only and 102 (19.8%) by FDA only.

Comparing NAS approved by both EMA and FDA (n=283), 50 (17.7%) are approved >1.5 years earlier by FDA and 21 (7.4%) > 1.5 years earlier by EMA. In contrast when comparing products approved by both PMDA and FDA or EMA, respectively (n=186 and n=189), approval is earlier by >1.5 years by FDA in 42.5% and by EMA in 37.6% of the cases, while PMDA is earlier by >1.5 years in only 5.9% (FDA) and 8.5% (EMA) of the cases.

This leads to a drug lag for both Europe and Japan compared to the US, which is especially visible for Japan.

CONCLUSIONS: Patients in Japan get later and/or limited access to innovative medications than patients in (1) the US and (2) Europe. Reasons why some NAS are not or later approved in these regions are subject to further research.