MHRA guidance on its assessment of non-clinical data generated outside OECD system
What was announced
MHRA issues new guidance on its approach to clinical trial applications that rely on non-clinical safety data generated outside the OECD Mutual Acceptance of Data system.
Key points, in the publisher's words
- The MHRA has today, 4th October 2026, published guidance explaining its patient-centred approach to clinical trial applications that rely on non-clinical safety data generated outside the Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data framework.
- The approach will help support a further risk-proportionate approach to clinical research, helping advance the development of new treatments and increase opportunities for UK patients to take part in trials.
- The OECD Mutual Acceptance of Data system provides an internationally recognised approach for generating non-clinical safety data, in line with agreed standards for testing and Good Laboratory Practice. Data generated within the framework remain the expected basis for UK clinical trial applications.
Who and where
UK bodies of power
- Medicines and Healthcare products Regulatory Agency (executive agency) · more news
Where this sits in the 10 levels of power
Topics, as GOV.UK files them: Vigilance, safety alerts and guidance.
Receipt
- Original: https://www.gov.uk/government/news/mhra-guidance-on-its-assessment-of-non-clinical-data-generated-outside-oecd-system
- Published 2026-11-04 15:23:20 UTC
- Read by this site 2026-11-04 15:30:04 UTC from GOV.UK
- Saved copy: receipt 8007, with its SHA-256 fingerprint
Contains public sector information licensed under the Open Government Licence v3.0.
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