Presentation (CTI)

OBJECTIVES: Post-Brexit, the UK introduced the International Recognition Procedure (IRP) on 1 January 2024, to expedite access to medicines and allow companies with Marketing Authorisations from MHRA-designated Reference Regulators (RRs) to seek UK approval using the same assessment (dossier). This study reviewed all IRP applications to date, comparing review processes across RRs, and assessed whether it has expedited access.
METHODS: IRP application data were obtained from the MHRA through a Freedom of Information (FoI) request, including details of products, IRP routes, RRs, submission types, and authorisation status. The analysis was restricted to new active substances and IRP route B, given Route B's broader eligibility criteria for innovative therapies. Duplicate entries for different doses of the same treatment were excluded.
RESULTS: As of 1 May 2025, 456 IRP applications had received decisions, originating from 19 RRs. These applications covered 25 active substances—11 via IRP Route A and 14 via Route B. Of the Route B applications, 11 were supported by EMA decisions, 2 by the US FDA, and 1 by Health Canada. The average review time for new active substances under Route B was 184 days. Notably, the three applications supported by the US FDA and Health Canada were authorised by the MHRA ahead of European Commission (EC) approval, whereas the remaining 11 substances became available in the EU before reaching the UK market.
CONCLUSIONS: Over the past 16 months, most IRP applications used EMA as the reference authority, likely reflecting that many applications were submitted to EMA prior to Brexit and received authorisation after the IRP launched. Three cases achieved UK approval before EMA authorisation through IRP. While these early examples demonstrate the IRP's potential to accelerate UK patient access to innovative therapies compared to the EU, a longer evaluation period is needed to fully assess its impact.