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.
The MHRA has today, 4th November 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.
The new guidance explains how the MHRA may consider non-clinical data generated outside the OECD framework in individual clinical trial applications where the available evidence and circumstances of the intended patient population support further regulatory consideration. It provides greater clarity for developers while maintaining standards for participant safety, scientific rigour and data integrity.