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Lookup NU author(s): Ayomikun OgunyemiORCiD, Cyril Onwuelazu UtehORCiD, Ross FairbairnORCiD, Dr Nick MeaderORCiD, Professor Dawn CraigORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
Objectives To understand the regulatory landscape in the UK and globally before the introduction of the Medicines and Healthcare Products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP). This paper aims to inform on the IRP's potential impact on access to innovative medicines, by comparing medicines approval in the UK with other international regulatory agencies. Methods A retrospective analysis of 154 technologies (medicine(s) + studied indication(s)) was conducted based on the National Institute for Health and Care Research (NIHR) Innovation Observatory (IO) technology briefings submitted to the National Institute for Health and Care Excellence (NICE) in 2020. These briefings serve as the trigger for the NICE Technology Assessment process. Data on the medicines’ submission and approval dates were extracted across 5 IRP reference regulators, which are the regulators from the United States (FDA), European Union (EMA), Japan (PMDA), Australia (TGA), and Singapore (HSA). The dates were compared with data from the UK (MHRA). Results Ninety-five (62%) medicines were approved by at least one regulatory agency, while 59 (38%) medicines were not approved by any regulatory agency. The number of medicines approved by the following regulatory agencies is FDA (n=84, 55%), EMA (n=80, 52%), MHRA (n=71, 46%), TGA (n=51, 33%), HSA (n=41, 27%), and PMDA (n=38, 25%). The first submissions were primarily to the FDA (n=64) or the EMA (n=24). The FDA had the highest number of first approvals (n = 70), followed by the EMA (n = 17) and the PMDA (n = 5). The FDA used more expedited pathways than other regulators (n = 61). Compared to the MHRA, FDA approvals were on average 360 days faster, and EMA approvals 86 days faster. Conclusion There were significant differences in market access timelines across the five reference regulators, with the FDA and EMA having the highest number of approved medicines, first submissions, and first approvals. IRP applications with the FDA or EMA as reference regulators may expedite access to innovative medicines in the UK by reducing the approval dates gap between the FDA/EMA and the MHRA. This understanding of the regulatory landscape will help inform future planning to accommodate the disruption that the IRP may cause.
Author(s): Ogunyemi A, Uteh C, Fairbairn R, Meader N, Craig D
Publication type: Article
Publication status: Published
Journal: BMJ Open
Year: 2025
Volume: 15
Issue: 11
Online publication date: 04/11/2025
Acceptance date: 02/10/2025
Date deposited: 08/10/2025
ISSN (electronic): 2044-6055
Publisher: BMJ Group
URL: https://doi.org/10.1136/bmjopen-2025-101643
DOI: 10.1136/bmjopen-2025-101643
Data Access Statement: The data that supports the findings of this study will be made available on request.
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