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MHRA sets out how non-OECD MAD non-clinical data can support UK trial applications

🇬🇧 MHRA · Wed 04 Nov 2026

New guidance describes a risk-proportionate framework for clinical trial authorisation applications relying on non-clinical data generated outside the OECD Mutual Acceptance of Data system.

The MHRA published guidance on 4 November 2026 explaining how it will consider non-clinical data generated outside the OECD Mutual Acceptance of Data (MAD) framework when assessing UK Clinical Trial Authorisation (CTA) applications. The agency says the growing use of specialist test facilities worldwide, many supporting medicines for serious, rare or high-unmet-need conditions, prompted the approach.

The guidance defines "non-OECD MAD data" broadly. It covers data from countries that are neither OECD members nor full MAD adherents, and data from facilities or test sites not covered by a recognised national GLP compliance monitoring programme, or whose GLP status has not been verified through one. A laboratory in an OECD or full-adherent country can therefore still fall into this category if it sits outside that country's monitoring programme. Labs outside such countries are not treated as within MAD, even if another authority has inspected them.

The MHRA stresses that a claim of GLP compliance, or a study run to OECD GLP principles or local GLP rules, does not give the same assurance as MAD coverage. The agency says studies under OECD GLP and MAD remain the primary and expected standard for pivotal non-clinical safety work.

The framework has three complementary streams, which may be used singly or together depending on the data package and the level of uncertainty. The source text describes them as covering inspection and compliance intelligence activities, an Enhanced Non-Clinical Assessment Pathway for eligible applications (criteria in Section 5.0 of the guidance), and a weight-of-evidence approach that may take clinical data into account. The excerpt available does not set out the detailed criteria or submission requirements.

Applications that do not meet the enhanced pathway criteria can still go through the standard CTA route, with non-OECD MAD data considered case by case. The MHRA describes this as its initial approach and says it may widen it to more therapeutic areas, trial phases or development settings, and refine it as experience builds. Assessment will be guided by participant safety, the totality of evidence, scrutiny proportionate to uncertainty and the importance of the data, and consideration of patient benefit and unmet need within the benefit-risk assessment.

What it means for your team

  • Check whether each non-clinical study site is covered by a national GLP compliance monitoring programme recognised under OECD MAD, not just whether it is in an OECD country or claims GLP compliance.
  • For packages including non-OECD MAD studies, review the full guidance, especially the Section 5.0 eligibility criteria for the Enhanced Non-Clinical Assessment Pathway, before planning a CTA submission.
  • Be prepared for case-by-case assessment if the enhanced pathway does not apply, and for MHRA to weigh the wider evidence, including clinical data where appropriate.
  • Monitor for updates, as the MHRA says the framework may be expanded or refined over time.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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