Primary source: Medicines and Healthcare products Regulatory Agency
A new liaison programme was established to deepen collaboration and enhance safety monitoring between MHRA and FDA, effective from 15 June 2026.
This programme will increase information sharing and potentially lead to more aligned regulatory inquiries and joint oversight activities, thereby improving safety monitoring and compliance.
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.
Regulatory Intelligence Lead
Review before 2026-06-15.
Establishment of a formal staff exchange and collaborative framework for safety monitoring and clinical research oversight between the UK and US.
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.
Reduced friction to market from the UK to the US and vice versa
Closer alignment in regulatory decisions
Enhanced day-to-day collaboration between MHRA and FDA
Dedicated liaison officer roles
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.
Published from the Firecrawl policy change extraction pipeline.
Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.
MAHs and sponsors must enhance their pharmacovigilance systems to monitor microbiome-specific safety issues, comply with established safety standards, and address concerns related to antimicrobial resistance.
Stakeholders, including manufacturers and clinicians, must review and potentially revise their post-market vigilance and safety monitoring protocols in response to the FDA's proposed regulatory approaches for generative AI devices.
Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.
