The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a comprehensive international reliance framework, marking a significant shift in its regulatory approach for both medicines and medical devices. This strategic move aims to accelerate market access while maintaining robust regulatory oversight in the post-Brexit landscape.
New Medical Device Recognition Framework
The MHRA's proposed international reliance system for medical devices introduces a tiered approach based on risk classification. The framework recognizes approvals from four comparable regulator countries (CRCs): Australia, Canada, the European Union, and the United States.
For low-risk devices, manufacturers need only declare compliance with quality management systems like ISO 13485. Higher-risk devices require submission of an International Medical Device Regulators Forum (IMDRF) dossier, though full review will occur only during post-market surveillance events.
Special considerations apply to advanced technologies such as Artificial Intelligence as Medical Devices (AIaMD), which require additional verification steps including premarket data review and implementation validation.
Streamlined Medicine Approval Process
Since January 2024, the MHRA has implemented the International Reliance Procedure (IRP), replacing previous European Commission procedures. This system enables expedited review of medicines already approved by seven trusted regulatory authorities, including the US, EU, Australia, Canada, Japan, Switzerland, and Singapore.
The IRP offers two recognition routes:
- Recognition A: A 60-day review for products approved by reference regulators within the past 2 years
- Recognition B: A 110-day review for products approved within the past 10 years, with additional scrutiny for complex cases
Market Impact and Strategic Context
This regulatory evolution responds to concerns about the UK's diminishing influence in the global pharmaceutical landscape, where it currently holds just 2.3% market share compared to the US's 43% and Europe's 22%. The initiative aligns with former Chancellor Jeremy Hunt's vision for "near automatic sign-off" for products approved by trusted regulators.
Northern Ireland Considerations
The implementation of the Windsor Framework in January 2025 has simplified the regulatory landscape for Northern Ireland, ensuring consistent medical product licensing across the UK market. This development streamlines the supply chain and eliminates the need for separate licensing procedures previously required under the Northern Ireland Protocol.
Quality Assurance and Oversight
Despite the expedited processes, the MHRA maintains its authority to reject applications deemed insufficiently robust. The agency requires manufacturers to maintain UK responsible persons and comply with post-market surveillance requirements, ensuring ongoing safety monitoring and regulatory compliance.
This regulatory transformation represents the MHRA's pragmatic response to increased post-Brexit responsibilities while striving to maintain its position as a globally recognized regulatory agency. The framework balances the need for efficient market access with comprehensive safety oversight, potentially serving as a model for other regulatory bodies worldwide.
