A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US

Mirre Scholte; Liam Bendicksen; Sabine E. Grimm; Teebah Abu-Zahra; Bianca Pauly; Manuela Joore; Aaron S. Kesselheim

doi:10.1017/jme.2024.171

A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US

Mirre Scholte, Liam Bendicksen, Sabine E. Grimm, Teebah Abu-Zahra, Bianca Pauly, Manuela Joore, Aaron S. Kesselheim^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.

Original language	English
Pages (from-to)	940-949
Number of pages	10
Journal	Journal of Law Medicine & Ethics
Volume	52
Issue number	4
DOIs	https://doi.org/10.1017/jme.2024.171
Publication status	Published - 1 Dec 2024

Keywords

Drug Repurposing
Prescription Drug Regulation
European Medicines Agency
US Food and Drug Administration
UK Medicines and Healthcare Products Regulatory Agency
Drug Approvals

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10.1017/jme.2024.171

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788669Licence: Other

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abstract = "To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.",

keywords = "Drug Repurposing, Prescription Drug Regulation, European Medicines Agency, US Food and Drug Administration, UK Medicines and Healthcare Products Regulatory Agency, Drug Approvals",

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AU - Bendicksen, Liam

AU - Grimm, Sabine E.

AU - Abu-Zahra, Teebah

AU - Pauly, Bianca

AU - Joore, Manuela

AU - Kesselheim, Aaron S.

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AB - To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.

KW - Drug Repurposing

KW - Prescription Drug Regulation

KW - European Medicines Agency

KW - US Food and Drug Administration

KW - UK Medicines and Healthcare Products Regulatory Agency

KW - Drug Approvals

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A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US

Abstract

Keywords

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