The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has debuted guidance laying out best practices for submitting unconventional non-clinical safety data in clinical trial applications (CTAs).
To support a more risk-proportionate approach to clinical research, the MHRA’s guidance specifically offers operators advice on how they can submit non-clinical safety data generated outside of the Organisation for Economic Co-operation and Development (OECD)’s data framework – which currently represents the expected basis for UK CTAs.
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In the guidance, the regulator notes that it may consider non-clinical data that falls outside of the OECD framework within individual applications, specifically in certain cases where further regulatory consideration is warranted. For example, this could stem from the stage and design of the trial, the context surrounding a specific patient population involved, or the severity and unmet needs associated with the condition in question.
This means that, in “limited circumstances,” the MHRA may consider an enhanced non-clinical assessment – including for first-in-human (FIH) studies in patients with serious or potentially life-threatening conditions who face significant unmet medical needs. The regulator said this move will allow for a proportionate approach to regulations, while protecting quality, safety and integrity standards.
On top of this, the agency also plans to perform strategic, risk-based inspections of non-clinical testing facilities that come up frequently in UK-submitted clinical trial applications. This, the MHRA says, will help to support the development of regulatory assessments in the future.
With information from inspections and compliance intelligence, the MHRA also voiced its intentions to evolve its approach as it accrues more knowledge – though the agency recommends that sponsors reach out early before submitting a CTA.
MHRA targets reforms amid wider UK government efforts
This guidance from the MHRA follows a period of significant regulatory reform for the regulator, which has recently focused on enhancing the competitiveness of the clinical trials landscape by evolving its approach and implementing technology to cut review times.
Recently, the agency debuted its 2030 Strategy, which detailed its ambitions to cut review times and implement artificial intelligence (AI) more deeply into the regulatory workflow.
Meanwhile, in the wider sphere of the British government, ministers are looking to give UK life sciences a boost, with policies like the Life Sciences Sector Plan aiming to supercharge the sector as it is deemed one of the UK’s “greatest national assets”.
However, in a previous conversation with Clinical Trials Arena’s sister publication, Pharmaceutical Technology, Ros Deegan, CEO of OMass Therapeutics, noted that the UK must focus on making itself a “launch market” to encourage the initiation of more late-stage clinical studies in the UK.
