Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

The research shows that, already by 2021, the use of RWD/RWE in pre-approval drug development was widespread and systematic among large pharmaceutical companies, even if this is not fully visible in public regulatory documents. Overall, the findings provide rare, direct industry evidence that RWD/RWE are already embedded in pre-marketing development and utilized to support EU regulatory submissions.