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.

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Publication Details

Journal
British Journal of Clinical Pharmacology
Published
2026-02-04
DOI
https://doi.org/10.1002/bcp.70471
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
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article

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

Leufkens Hg, Sini Marika Eskola, Marie L. De Bruin, Aleksandar Gigov et al.
British Journal of Clinical Pharmacology
Pharmaceutical Economics and Policy
article

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

Leufkens Hg, Sini Marika Eskola, Marie L. De Bruin, Aleksandar Gigov, Andrew Bate
article en

Abstract

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.

British Journal of Clinical Pharmacology
University of Iceland (IS), Utrecht University (NL), University Medical Center Utrecht (NL), Takeda (Switzerland) (CH), London School of Hygiene & Tropical Medicine (GB), Pharmo Institute (NL), Nederlandse Internisten Vereniging (NL)
Good health and well-being
Openalex Percentile: Top 69%
Pharmaceutical Economics and Policy
DOISourceOpenAlex
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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 — Leufkens Hg, Sini Marika Eskola, et al. · British Journal of Clinical Pharmacology (2026) | TGRS Research Map | TGRS