<b>A regulatory roadmap for repurposing: comparing pathways for making repurposed drugs available in the EU, UK, and US </b>

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. We found no pathways specifically for repurposed drugs, however pathways to market are available in all repurposing scenarios.

Content

Author and article information

Journal

Title: DrugRxiv

Publisher: REPO4EU

Publication date (Electronic preprint): 18 November 2024

Affiliations

[1 ] departments of IQ health radiology at Radboudumc, Nijmegen, the Netherlands ( https://ror.org/05wg1m734)

[2 ] department of Clinical Epidemiology & Medical Technology Assessment (KEMTA), Maastricht University Medical Centre, Maastricht, The Netherlands ( https://ror.org/02d9ce178)

[3 ] Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands ( https://ror.org/02jz4aj89)

[4 ] Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts, USA ( https://ror.org/04b6nzv94)

[5 ] 3D-PharmXchange, Tilburg, The Netherlands;

[6 ] Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA. ( https://ror.org/04b6nzv94)

Author notes

[* ]Email: mirre.scholte@ 123456radboudumc.nl .

Author information

Mirre Scholte https://orcid.org/0000-0003-3102-6011

Article

DOI: 10.58647/DRUGARXIV.PR000018.v1

SO-VID: 6099ceed-48db-443f-b12a-df72c9ffb693

License:

This work has been published open access under Creative Commons Attribution License CC BY 4.0 , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Conditions, terms of use and publishing policy can be found at www.scienceopen.com .

History

Date received : 18 November 2024

Funding

Funded by: funder-id http://dx.doi.org/10.13039/100018696, HORIZON EUROPE Health;

Award ID: 101057619

A regulatory roadmap for repurposing: comparing pathways for making repurposed drugs available in the EU, UK, and US

Abstract