The UK International Recognition Procedure (IRP): Accelerating Access to Medicines Through Global Regulatory Collaboration
The MHRA's International Recognition Procedure (IRP) is transforming how medicines reach UK patients by leveraging trusted international regulatory decisions. Learn how the IRP works, its benefits, recent performance insights, and what it means for pharmaceutical companies.
The UK International Recognition Procedure (IRP): Accelerating Access to Medicines Through Global Regulatory Collaboration
Since leaving the European Union, the UK has been reshaping its medicines regulatory landscape to remain both globally competitive and scientifically robust. One of the most significant developments has been the introduction of the International Recognition Procedure (IRP) by the Medicines and Healthcare products Regulatory Agency (MHRA).
Implemented on 1 January 2024, the IRP represents a modern regulatory pathway that enables the MHRA to leverage assessments already completed by trusted international regulators while maintaining its own independent decision-making authority. Rather than duplicating scientific reviews, the IRP allows the Agency to perform targeted assessments, helping bring medicines to UK patients more quickly without compromising safety, quality or efficacy.
For pharmaceutical companies, the IRP offers an important opportunity to optimise regulatory strategy, reduce approval timelines, and improve access to the UK market.
Why the IRP matters
Developing and registering medicines is increasingly global.
Many products receive approvals from multiple regulatory authorities, often based on substantially similar scientific data packages. Historically, manufacturers have had to undergo separate, independent assessments in each jurisdiction, creating duplication of effort and extending timelines.
The International Recognition Procedure addresses this challenge by allowing the MHRA to consider decisions from selected Reference Regulators (RRs) while retaining responsibility for the final UK marketing authorisation decision.
The result is a regulatory framework that aims to deliver:
- Faster patient access to innovative medicines
- Reduced duplication of regulatory assessments
- More efficient use of regulatory resources
- Greater international collaboration
- Continued assurance of high scientific standards
Which regulators can support an IRP application?
The MHRA currently recognises approvals from several trusted international regulators, including:
- European Medicines Agency (EMA) and EU/EEA Member States
- US Food and Drug Administration (FDA)
- Health Canada
- Swissmedic
- Therapeutic Goods Administration (Australia)
- Pharmaceuticals and Medical Devices Agency (Japan)
- Health Sciences Authority (Singapore)
Certain approvals from the Access Consortium are also eligible where the MHRA was not part of the original work-sharing procedure.
Which products are eligible?
The IRP is available for a wide range of marketing authorisation applications, including:
- New active substances
- Chemical medicines
- Biological medicines
- Generic medicines
- Hybrid applications
- Biosimilars
- Fixed-dose combination products
In addition to initial marketing authorisations, the IRP can also be used for:
- Line extensions
- Type IB variations
- Type II variations
- Renewals
Certain application types, including bibliographic applications and traditional herbal or homeopathic registrations, remain outside the scope of the procedure.
Understanding Recognition Route A and Route B
The IRP offers two assessment pathways depending on the complexity of the application and the timing of the reference regulator approval.
Recognition Route A
Recognition A is designed for straightforward applications where the reference regulator approval has been granted within the previous two years.
Key characteristics include:
- 60-day assessment timetable
- No planned clock stop
- Streamlined targeted assessment
- Faster route to approval
Recognition Route B
Recognition B supports more complex products or situations where additional assessment is appropriate.
Examples include:
- Orphan medicines
- Advanced Therapy Medicinal Products (ATMPs)
- First-in-class products
- Novel technologies
- Conditional approvals
- Older reference approvals
Recognition B follows:
- 110-day assessment timetable
- One planned clock stop where necessary
- Additional scientific review when appropriate
Should significant issues remain unresolved, applications may transition to the standard national assessment process.
How successful has the IRP been?
Although the MHRA has not published a cumulative total number of IRP approvals since the procedure launched, publicly available performance data demonstrates strong uptake and timely delivery.
Some notable milestones include:
- The first medicine approved via the IRP received UK authorisation in February 2024, demonstrating the Agency's ability to complete an accelerated assessment using the new framework.
- MHRA operational metrics published during 2025 show that Recognition Route A initial marketing authorisation applications consistently achieved 100% of approvals within the statutory assessment timeframe, with average review times significantly shorter than the traditional national procedure.
- The Agency also reported excellent performance for post-authorisation procedures submitted through the IRP, including hundreds of Type IB and Type II variation approvals completed within statutory timelines. For example, January 2025 operational data showed 273 IRP Type IB variations and 180 IRP Type II variations granted, with 98–100% meeting statutory timelines.
These figures suggest that the IRP is becoming an increasingly important component of the UK's regulatory toolkit and that the MHRA is consistently meeting its ambitious review targets.
Strategic advantages for pharmaceutical companies
For sponsors developing global regulatory strategies, the IRP provides several important benefits.
Earlier UK market access
Companies can leverage approvals from trusted regulators to obtain UK authorisation more rapidly than through the standard national procedure where eligibility criteria are met.
Greater regulatory efficiency
Using existing regulatory assessments reduces duplication and enables more focused preparation of UK submissions.
Flexible lifecycle management
The IRP supports not only initial marketing authorisations but also post-authorisation lifecycle activities, making it a valuable long-term regulatory pathway.
Global regulatory alignment
The procedure allows companies to better coordinate global filing strategies while maintaining compliance with UK-specific requirements.
Points sponsors should consider
While the IRP offers significant advantages, successful submissions still require careful planning.
Sponsors should:
- Select the most appropriate Reference Regulator
- Ensure product comparability between jurisdictions
- Prepare comprehensive reference regulator assessment documentation
- Consider timing carefully when planning global submissions
- Maintain alignment between UK and reference regulator dossiers where possible
The MHRA continues to perform its own targeted scientific assessment and retains the authority to request additional information or decline applications where the evidence is considered insufficient.
Looking ahead
The International Recognition Procedure represents an important evolution in UK medicines regulation.
Combined with initiatives such as the Innovative Licensing and Access Pathway (ILAP), strengthened international collaboration, and continued digital transformation, the IRP reinforces the UK's ambition to remain one of the world's leading regulatory environments for innovative medicines.
As pharmaceutical development becomes increasingly global, reliance and recognition pathways are expected to play an even greater role in reducing duplication, accelerating patient access, and improving regulatory efficiency.
For companies developing global registration strategies, understanding how and when to utilise the IRP will become an increasingly valuable competitive advantage.
Final thought
The MHRA's International Recognition Procedure demonstrates that faster approvals do not require lower regulatory standards.
By combining international collaboration with independent scientific oversight, the IRP delivers a pragmatic regulatory model that benefits patients, regulators, and industry alike.
For pharmaceutical companies, the opportunity is clear: organisations that integrate the IRP into their global regulatory strategy can achieve more efficient UK approvals while maintaining the high-quality submissions expected by the MHRA.
Need support with your UK regulatory strategy?
Whether you are planning an initial IRP submission, selecting the most appropriate Reference Regulator, or managing post-authorisation lifecycle activities, Regvista provides strategic regulatory support to help optimise UK marketing authorisation pathways and accelerate successful approvals.
At Regvista, we remain committed to support biopharmaceutical leaders navigating their transformative journey—bringing cutting-edge therapies to market faster and safer. Please feel free to contact us by submitting your enquiry to deployment@regvista.co.uk