UK MHRA issues new guidance on accepting non-OECD safety data for clinical trial applications

The UK Medicines and Healthcare products Regulatory Agency has published new guidance allowing case-by-case assessment of certain non-clinical safety data generated outside the OECD Mutual Acceptance of Data framework for clinical trial applications.

The guidance published on 4 November 2026 maintains OECD-aligned Good Laboratory Practice data as the expected standard while establishing a risk-proportionate enhanced assessment approach for limited circumstances, including first-in-human studies addressing serious or life-threatening conditions with substantial unmet medical need.

The MHRA also plans risk-based inspections of relevant non-clinical testing facilities, making the policy a targeted regulatory assessment pathway rather than blanket acceptance of non-OECD data or a reduction in patient-safety requirements.

Field	Content
Article Type	Industry Updates
Regulatory Authority	Medicines and Healthcare products Regulatory Agency
Abbreviation	MHRA
Country	United Kingdom
Announcement Date	4 November 2026
Update Type	New regulatory guidance
Guidance Subject	Use of non-OECD MAD non-clinical data in UK clinical trial authorisation applications
Regulatory Framework	OECD Mutual Acceptance of Data
Abbreviation for Framework	OECD MAD
Expected Data Standard	OECD-aligned Good Laboratory Practice
Good Laboratory Practice Abbreviation	GLP
Regulatory Application	Clinical trial authorisation
Data Category	Non-clinical safety data
Alternative Data Origin	Testing performed outside the OECD MAD framework
Assessment Approach	Case-by-case risk-proportionate enhanced assessment
Applicable Circumstances	Limited situations where the MHRA considers enhanced assessment appropriate
Example Clinical Context	First-in-human studies involving serious or life-threatening conditions with substantial unmet medical need
Inspection Approach	Risk-based inspections of relevant non-clinical testing facilities
Patient Safety Position	Patient-safety requirements remain in place
Blanket Acceptance	No; non-OECD data are not automatically accepted
Automatic GLP Exemption	No blanket exemption announced
Regulated Stakeholders	Clinical trial sponsors; pharmaceutical developers; non-clinical testing organisations
What Happened	The MHRA published guidance describing how non-clinical data generated outside the OECD MAD system may be assessed for UK clinical trial applications.
Why It Matters	The guidance provides a defined assessment route for certain international non-clinical data packages while preserving regulatory oversight.
Regulatory Significance	Introduces a risk-proportionate approach to considering otherwise non-standard non-clinical data in limited clinical trial settings.
Practical Implications	Sponsors may need additional justification, supporting evidence and regulatory engagement when submitting non-OECD data.
Key Takeaway	The MHRA may consider selected non-OECD non-clinical data through enhanced assessment without abandoning expected GLP standards.
What to Watch	Implementation of the guidance, inspection practices, sponsor experience and future MHRA clarifications.
Primary Source	UK Medicines and Healthcare products Regulatory Agency
Primary Source URL	https://www.gov.uk/guidance/use-of-non-oecd-mad-non-clinical-data-in-support-of-uk-clinical-trial-authorisation-applications
Relevant Date	4 November 2026

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