MHRA's International Recognition Procedure: Fast-Track Access to the UK Market

What Is MHRA’s International Recognition Procedure?

The MHRA’s IRP is a streamlined regulatory pathway for medicines that have already been approved by a specified list of reference regulators.

This article explores the strategic implications of the International Recognition Procedure (IRP) for regulatory and market access planning, highlighting key procedural elements and considerations for NICE appraisals. 

Why IRP Matters for UK Drug Approval

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched the IRP on 1st January 2024, marking a pivotal shift in the UK’s post-Brexit regulatory landscape. The procedure replaced the EC Decision Reliance Procedure (ECDRP) and is designed to streamline access to the UK market by leveraging approvals from so-called ‘trusted’ international regulators. This pragmatic procedure supports the UK’s 10-Year Health Plan and the UK Clinical Research Delivery (UKCRD) programme by enabling faster access to high-quality medicines through reliance on trusted global regulators, reducing duplication and accelerating approvals.

Key Aspects of the MHRA IRP

The ECDRP, introduced in January 2021, allowed the MHRA to rely on European Commission decisions for a limited period following Brexit. Initially intended to last two years, it was extended through December 2023. As of January 2024, the IRP fully replaced the ECDRP, expanding the scope of recognition to include approvals from seven Reference Regulators (RRs): EMA and member state competent authorities, FDA, Health Canada, Swissmedic, PMDA, TGA and HSA Singapore. These regulators were selected based on their reputation for conducting full, standalone regulatory reviews and maintaining high standards of scientific and regulatory rigor.

Procedurally, the IRP offers two distinct pathways for initial marketing authorisation and line extensions: 

*Route B allows for entry under any of 23 listed criteria. Please refer to MHRA website for more details. 

According to recent insights from MHRA, EMA dossiers are likely to be processed under Route A, enabling a 60-day review, while other RRs are more likely to be processed via the longer Route B review. 

Performance Metrics and Timelines

From its August 2025 performance metrics, MHRA reported up to 40% of UK marketing authorisations now go through the IRP and that, on average, Route A takes 43 days, while Route B takes 89 days - both substantially shorter than the targeted 60 and 110 days, respectively.

Route A offers an expedited review that is far less resource-intensive than a full MHRA submission. But it does mean UK approval comes after EMA approval, albeit only a matter of weeks later.

Route B on the other hand enables an earlier approval because it references other global RRs. Typically, the US FDA is the first to grant global approval and, based on current data, UK approval under Route B would come on average less than three months later. This makes the UK an attractive early launch market.

UK Market Access After MHRA IRP

Why Faster Approval Doesn’t Equal Faster Access

Together with other initiatives such as the Innovative Licensing and Access Pathway (ILAP), Early Access to Medicines Scheme (EAMS), Project Orbis and the Access Consortium, the UK Government is working hard to introduce policies that make the UK an attractive launch market for innovative medicines post-Brexit. 

However, faster regulatory approval does not necessarily equate to faster access to patients. Products must still undergo health technology assessment (HTA) to be recommended for use in the NHS (for example, via the National Institute for Health and Care Excellence [NICE]). These regulatory policies therefore need to work in concert with the practicalities of securing market access — notably the evidence and pricing constraints that govern these decisions. 

Challenges with NICE Evidence Requirements

NICE evidence requirements remain unchanged, and products approved via conditional or accelerated regulatory pathways may lack long-term data, creating uncertainties in the cost-effectiveness analysis. In recent years, there has been a rise in terminated NICE appraisals, often due to immature data or insufficient cost-effectiveness evidence. 

However, the bigger issue is the pricing environment in the UK. In recent months, big pharma companies have reversed significant investment decisions, citing the unfavourable commercial operating environment in the UK. 

In September 2025, Merck & Co. cancelled a planned £1bn ($1.36bn) London research centre. The same month, AstraZeneca paused a £200m ($271m) expansion of its Cambridge research site, and earlier in the year cancelled a £450m vaccine manufacturing facility in Liverpool, UK. The company has also announced plans to move its primary stock listing from London to New York.  

In response to these events and President Trump’s Executive Order on Most-Favoured-Nation (MFN) Prescription Drug Pricing, the UK Government is revisiting its cost-effectiveness threshold for evaluating new medicines. In October an increase of 25% was reportedly being considered, which would take it from £20,000–£30,000 per Quality Adjusted Life Year (QALY) to approximately £25,000–£37,500. 

The NICE threshold has remained unchanged since 1999, and so we see this potential policy change as a significant (and long-overdue) development in the UK Government recognizing the value in rewarding innovation. 

How Biotech and Pharma Can Leverage MHRA IRP for Faster UK Launch

The IRP offers an important opportunity to support manufacturers in their global regulatory submission strategy – by leveraging global RRs to secure UK marketing authorisation with a substantially reduced work burden and faster timelines versus the pre-2024 arrangements.

However, to be effective, regulatory schemes such as this need to be aligned with downstream access requirements and pricing conditions. We are now beginning to see some movement on these fronts, which is a welcome sign for the UK pharmaceutical industry. 

Much as government policy needs to be aligned on regulatory, access and pricing, so does company strategy. At Precision, we guide biotech and pharma companies through UK regulatory and HTA pathways, providing a joined-up approach that spans strategic planning and early scientific advice through to dossier submission.

Partner with Precision to ensure your UK market entry is seamless and successful.