OBJECTIVES: This 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).

METHODS: A 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.

RESULTS: FDA 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.

CONCLUSIONS: There 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.