PV Bulletin

Unique Liaison Programme between MHRA and FDA

The MHRA and US FDA have launched a new liaison programme aimed at strengthening regulatory collaboration.

Primary source: Medicines and Healthcare products Regulatory Agency

PV Impact Brief

MonitoringConfidence: high

What changed

A new liaison programme was established to deepen collaboration and enhance safety monitoring between MHRA and FDA, effective from 15 June 2026.

Why it matters

This programme will increase information sharing and potentially lead to more aligned regulatory inquiries and joint oversight activities, thereby improving safety monitoring and compliance.

Action needed

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Relevant for
Regulatory Intelligence LeadSignal Management LeadQPPV
Processes impacted
Signal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-06-15.

Policy change details

Document type
Notice
Policy status
new
Publication date
2026-06-15
Effective date
2026-06-15
Policy change
The MHRA and US FDA have launched a new liaison programme aimed at strengthening regulatory collaboration. The programme focuses on innovation, clinical research standards, and enhanced safety oversight through staff exchanges and shared regulatory insights.

Key changes

Establishment of a formal staff exchange and collaborative framework for safety monitoring and clinical research oversight between the UK and US.

Affected workflows

Signal ManagementCountry Compliance

Responsible groups

Global PV StrategyRegulatory AffairsQPPV

PV impact

Increases the level of information sharing between the two regulators regarding safety signals and clinical trial oversight. MAHs may see more aligned regulatory inquiries or joint oversight activities.

View regulator source

Source document details

Exact policy details

Liaison Programme Announcement Date
15 June 2026
Applies to: Both MHRA and FDA
Published on 15 June 2026 · p. 1 · High · Source
Focus Areas of Collaboration
Innovative medicines, medical devices, and emerging technologies such as AI
Applies to: Both MHRA and FDA
Formalises and deepens cooperation between the two agencies across key focus areas · p. 1 · High · Source

Workflow rule impacts

Country ComplianceMHRA and FDA

Reduced friction to market from the UK to the US and vice versa

Closer alignment in regulatory decisions

Our regulatory decisions will become more closely aligned, reducing friction to market · p. 1 · High · Source
Country ComplianceMHRA and FDA

Enhanced day-to-day collaboration between MHRA and FDA

Dedicated liaison officer roles

Establish dedicated, reciprocal liaison officer roles within each organisation · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jun 15, 2026

Full briefing

Practical implication

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

The MHRA and FDA have announced a liaison programme that enhances collaboration in key areas such as innovative medicines and medical devices through dedicated liaison officer roles. This initiative is aimed at improving regulatory decisions and safety oversight, and will be effective from 15 June 2026.

What changed: A new liaison programme was established to deepen collaboration and enhance safety monitoring between MHRA and FDA, effective from 15 June 2026.

Why it matters: This programme will increase information sharing and potentially lead to more aligned regulatory inquiries and joint oversight activities, thereby improving safety monitoring and compliance.

Practical implication: MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#new#policy-change#Guidance#firecrawl-policy-agent#Notice#Medicines and Healthcare products Regulatory Agency

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