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Lookup NU author(s): Ayomikun OgunyemiORCiD, Cyril Onwuelazu UtehORCiD, Ross FairbairnORCiD, Dr Nick MeaderORCiD, Professor Dawn CraigORCiD
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ObjectivesThis paper aims to explore the regulatory timelines of innovative medicines in the UK and globally, assessing the potential outcomes of the Medicines and Healthcare products Regulatory Agency’s (MHRA) new International Recognition Procedure (IRP), with a focus on 5 of the IRP’s global Reference Regulators (RR). MethodsA retrospective analysis of 154 technologies (medicine(s) + studied indication(s)) was conducted based on all the technology briefings submitted by the National Institute of Health and Care Research (NIHR) Innovation Observatory (IO) to the National Institute of Health and Care Excellence (NICE) in 2020.Data sources included IO repositories, regulatory agencies’ data, company websites, Citeline’s Biomedtracker, clinical trial registries, and hand searching. Data on technologies’ submission and approval dates were extracted across 5 IRP RRs, which are the regulators from United States (FDA), European Union (EMA), Japan (PMDA), Australia (TGA) and Singapore (HSA). The dates were compared with data from the MHRA. ResultsFDA approved 84 technologies, EMA approved 80 and MHRA approved 71 technologies. TGA, HSA and PMDA all approved less technologies. First submissions were mostly to FDA (n=64) or EMA (n=24). FDA had the highest number of first approvals (n=70), followed by EMA(n=17) and PMDA (n=5). The average time difference between FDA and MHRA approvals was 360 days, and 86 days between EMA and MHRA, in favor of the FDA and EMA. ConclusionsThere were significant differences in market access timelines using approval dates across the 5 RRs, with the FDA and EMA taking the lead, with the highest number of approved technologies, and the shortest time to approval, compared to other RRs. IRP applications with the FDA or EMA as RR may expedite access to innovative technologies in the UK by reducing the submission gap between the FDA/EMA, and the MHRA.
Author(s): Ogunyemi A, Uteh C, Fairbairn R, Meader N, Craig D
Publication type: Conference Proceedings (inc. Abstract)
Publication status: Published
Conference Name: ISPOR Europe 2024
Year of Conference: 2024
Pages: S313-S314
Print publication date: 25/12/2024
Online publication date: 25/12/2024
Acceptance date: 01/12/2024
ISSN: 1098-3015
Publisher: Elsevier
URL: https://doi.org/10.1016/j.jval.2024.10.1629
DOI: 10.1016/j.jval.2024.10.1629
