MHRA's International Recognition Procedure: Fast-Track Access To The UK Market

By John McIntyre, Ph.D.; and Alex Grosvenor

The International Recognition Procedure (IRP) is a new MHRA pathway that allows medicines already approved by selected “trusted” regulators to enter the UK through a streamlined review, replacing the earlier EC Decision Reliance Procedure. It introduces two routes: Route A, generally used for EMA-based dossiers with a targeted 60‑day review, and Route B, which relies on other global regulators and can secure UK approval only a few months after the first worldwide authorization. Recent performance metrics show both routes beating target timelines, with a growing share of UK marketing authorisations now using IRP.

Faster approval alone, however, does not guarantee faster patient access. Manufacturers must still satisfy NICE and other HTA bodies with robust clinical and economic evidence, which can be challenging for products approved on conditional or accelerated bases with immature data. At the same time, a difficult UK pricing environment has led some major companies to scale back planned investments, prompting policy debates about raising long‑standing cost‑effectiveness thresholds. Against this backdrop, aligning IRP use with UK access and pricing strategy becomes critical. Sponsors that integrate regulatory planning, HTA requirements, and pricing early in development are best positioned to use IRP to achieve both rapid authorization and timely reimbursement in the NHS.