The Medicines and Healthcare products Regulatory Agency (MHRA) may weigh safety findings from non-clinical studies outside the OECD framework in U.K. trial applications, considering who would take part and how the study is designed.
The MHRA published the guidance Nov. 4. It describes the OECD framework as a common route for producing non-clinical safety evidence under agreed testing methods and Good Laboratory Practice. Evidence produced under the framework remains the standard starting point for U.K. applications.
For an application relying on evidence from outside the framework, MHRA may consider the available findings in the context of the proposed study. Factors include the people enrolled, how serious their condition is, unmet medical need, and the study’s stage and design.
In a limited set of cases, the agency may use a more intensive non-clinical review. That could include first-in-human studies for patients with advanced cancer or illnesses that are serious or life-threatening when significant medical needs remain unmet.
The agency says the guidance leaves current expectations for pivotal non-clinical evidence unchanged, including standards for quality, safety and data integrity. The agency says its approach is intended to preserve participant safeguards and scientific rigor while giving developers a clearer picture of how evidence will be weighed. It may also support research and broaden opportunities for U.K. patients to participate in trials.
The agency will conduct risk-based inspections of non-clinical testing facilities that appear frequently in U.K. applications. Results are expected to help shape later regulatory assessments. MHRA says its approach may develop as it gains regulatory experience, compliance intelligence and inspection results.
Developers preparing applications that rely on non-OECD evidence are encouraged to engage with MHRA early in the process.
