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      Abstract submission is now open for RExPO25, the 4th International Conference on Systems Medicine, AI & Drug Repurposing.  Submit your proposal for a talk or poster and join us in Barcelona, Spain, September 24-26, 2025. 

      Deadline for abstracts is June 30, 2025

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

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      research-article

            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. 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
            Author information
            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
            Categories

            Data availability: All data generated or analysed during this study are included in this published article (and its supplementary information files).
            ScienceOpen disciplines: Law
            Keywords: drug approvals,UK Medicines and Healthcare products Regulatory Agency,US Food and Drug Administration,European Medicines Agency,prescription drug regulation,Drug repurposing

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