Unlocking Global Markets: The UK’s Pioneering Approach to International Regulatory Recognition

Introduction: A New Era of Regulatory Agility

Post-Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has redefined its regulatory framework to accelerate patient access to innovative therapies and medical devices. The cornerstone of this transformation? The International Recognition Procedure (IRP), launched in January 2024. This paradigm shift allows the MHRA to leverage approvals from trusted global regulators—slashing review times by 50–70% while maintaining rigorous safety standards 13. For pharmaceutical and medtech companies, this isn’t just a procedural update; it’s a strategic gateway to the UK’s 70 million-strong market.

Section 1: The IRP Framework for Medicines

1.1 Core Principles and Eligibility

The IRP replaces the outdated EC Decision Reliance Procedure, accepting prior approvals from 10+ reference regulators (RRs), including:

FDA (USA), EMA (EU), Health Canada, TGA (Australia), PMDA (Japan), and SwissMedic 13.

Eligible products span new chemical/biological entities, generics, biosimilars, and fixed-dose combinations. Exclusions include herbal medicines and homeopathic products 13.

1.2 Dual-Track Timelines: Speed vs. Complexity

Recognition A (60-day pathway):
For RR approvals ≤2 years old.
No clock stops; ideal for straightforward applications with identical manufacturing processes 14.
Recognition B (110-day pathway):
For RR approvals ≤10 years old.
Mandatory for complex cases (e.g., ATMPs, orphan drugs, products with UK-specific risk plans) 13.
Includes one clock stop at Day 70 for major objections 1.

Table: IRP Performance Metrics (Jan 2025)

Application Type	Avg. Approval Time	Within Timeline
Type IB IRP Variations	8 days	100%
Type II IRP Variations	37 days	98%
NAS IRP Route B	107 days	100%	3

Section 2: Medical Devices – The Four-Route Recognition System

In 2024, the MHRA proposed a groundbreaking framework for devices, accepting approvals from Australia (TGA), Canada (Health Canada), EU (EMA), and the US (FDA) 810.

2.1 Key Access Routes

Route	Eligible Devices	Approved Body Review
Route 1	Class I non-sterile MDs; Class A IVDs	Self-declaration (QMS only)
Route 3	Class IIa/IIb MDs; Class B/C IVDs (from non-EU RRs)	Review of PMS data + implant labeling
Route 4	Active devices; SaMD; Class IIb implants (510(k))	Enhanced checks (equivalence, electrical safety) 10

Critical exclusions:

Devices approved via reliance routes in reference countries.
Companion diagnostics with unlicensed medicinal substances 8.

2.2 CE Marking: Toward Indefinite Recognition?

Amid industry pressure, the MHRA is reconsidering its 2030 sunset clause for CE-marked devices. Stakeholders argue Route 2 (EU device review) creates redundancy. Solution? Potentially indefinite CE recognition—simplifying market entry for EU-approved devices 10.

Section 3: Strategic Advantages for Industry

3.1 Accelerated Market Access

IRP cuts initial MA approval to 60–110 days vs. 210 days nationally 34.
Post-authorization variations (Type IB) clear in 8 days avg. under IRP vs. 14 days nationally 3.

3.2 Cost and Resource Efficiency

Leveraging existing dossiers reduces duplication. Only UK-specific Module 1 (e.g., labeling, naming) requires customization 4.
But note: MHRA may reject invented names over safety concerns (e.g., similarity to UK-marketed products) 4.

3.3 Global Sequencing Flexibility

Companies can now prioritize non-EU markets first (e.g., FDA → IRP → UK → EMA).
APAC firms with Japan/Singapore approvals gain streamlined UK access 4.

Section 4: Navigating Implementation Challenges

4.1 Medicines: The "Same Product" Hurdle

IRP requires identical formulations, manufacturers, and licensees as the reference product. Third-party applicants must prove they can fulfill UK obligations 3.

4.2 Devices: UDI and UKCA Symbol Reform

UDI becomes mandatory: Physical UKCA markings may be phased out, replaced by digital UDI tracking in public databases 10.
IVD reclassification: Class B IVDs now require ISO 13485 QMS certification—diverging from EU IVDR routes 10.

Section 5: Future Directions

AI-Enhanced Assessments:
MHRA plans AI tools to predict safety risks using global submission data 3.
Device Route Expansion:
Route 4 now includes SaMD and 510(k)-cleared Class IIb implants (pending equivalence proof) 10.
3D-Printed Patient-Specific Tools:
Custom surgical devices may soon utilize abridged reviews 8.

Strategic Recommendations for Industry

Pre-Submission Optimization:
Use MHRA’s eligibility checker 6 weeks pre-submission 3.
Attend MHRA pipeline meetings (2–5 years pre-submission) 4.
Lifecycle Management:
IRP covers variations/renewals—even for nationally approved products 13.
Device-Specific Action Items:
Prepare IMDRF-format dossiers and UK implant cards 8.
Monitor consultations on CE marking’s indefinite extension 10.

Conclusion: The UK as a Global Regulatory Catalyst

The IRP isn’t just a procedural shortcut; it’s a strategic realignment of the UK’s role in global health innovation. By bridging trusted international approvals with local oversight, the MHRA balances speed and safety—setting a blueprint for agile 21st-century regulation. For industry, this means faster patient access, leaner resource allocation, and newfound flexibility in global rollout sequences. As AI integration and device reforms mature, the UK solidifies its position as a launchpad for transformative therapies.

"Regulatory agility is no longer a luxury—it’s the currency of patient access. The IRP positions the UK at the forefront of this shift."

Key Resources

MHRA IRP Guidance (Latest: May 2025) 12
Parexel’s Global Submission Strategy Toolkit 4
UK Device UDI Database 10

FAQs

Q: Can a US company without a UK entity apply via IRP?
A: No. Applicants must be established in the UK, EU, or EEA to fulfill legal obligations 3.

Q: Does IRP accept 510(k)-cleared SaMD?
A: Currently excluded from device routes, but MHRA is reconsidering for Route 4 10.

Q: How does IRP impact Northern Ireland?
A: Until 2025, EU Centralized Procedure products can only be authorized in Great Britain 1.

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