MHRA关于其评估在OECD体系外生成的非临床数据的指南
正文 · 中文译文
新闻稿 MHRA关于其评估在OECD体系外产生的非临床数据的指南 MHRA发布新指南，阐述其对依赖在OECD相互接受数据体系外产生的非临床安全性数据的临床试验申请的处理方式。 发布机构： 药品和医疗保健产品监管局 发布日期： 2026年11月4日 MHRA于今日，2026年11月4日，发布指南，说明其以患者为中心的处理方式，适用于依赖在经济合作与发展组织（OECD）相互接受数据框架之外产生的非临床安全性数据的临床试验申请。 该方法将有助于支持对临床研究采取进一步的风险相称方法，帮助推进新疗法的开发，并增加英国患者参与试验的机会。 OECD相互接受数据体系提供了一种国际公认的非临床安全性数据生成方法，符合商定的测试标准和良好实验室规范。在该框架内产生的数据仍是英国临床试验申请的预期基础。 新指南说明了MHRA在个别临床试验申请中可如何考虑在OECD框架之外产生的非临床数据，前提是现有证据和预期患者人群的情况支持进一步的监管考量。它为开发者提供了更大的明确性，同时维持参与者安全、科学严谨性和数据完整性的标准。 在该方法下，MHRA将结合拟开展试验的具体情况，综合考虑现有的非临床证据。这些情况包括受试者人群、疾病的严重程度、未被满足的医疗需求以及试验的阶段和设计。 因此，在有限的情况下，MHRA可能会考虑进行强化的非临床评估，包括针对晚期癌症或其他严重或危及生命的疾病且存在显著未被满足医疗需求的患者开展首次人体试验。在适当情况下，这将对现有证据提供额外的科学审查。 除对各项申请进行评估外，MHRA还将开展一项战略性、基于风险的检查计划，对在英国临床试验申请中频繁出现的非临床测试设施进行检查。这将有助于为未来的监管评估提供信息，并支持采用相称的、基于证据的监管监督方法。 该指南不改变对关键性非临床安全性数据的质量、安全性或完整性所期望的标准。它更清晰地阐明了MHRA将如何评估现有证据并对各项申请实施相称的监管审查。 MHRA的方法将随着监管经验、合规情报和测试设施检查结果的积累而不断发展。 计划使用在OECD数据互认体系之外生成的非临床数据的开发者，鼓励在提交临床试验申请之前尽早进行沟通。 欲了解更多信息，请阅读《使用非OECD最大耐受剂量（MAD）非临床数据支持英国临床试验授权申请——GOV.UK》
正文 · 英文原文
News story MHRA guidance on its assessment of non-clinical data generated outside OECD system 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. From: Medicines and Healthcare products Regulatory Agency Published: 4 November 2026 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. Under this approach, the MHRA will consider the available non-clinical evidence alongside the circumstances of the proposed trial. This includes the participant population, the seriousness of the condition, unmet medical need and the stage and design of the trial. Accordingly, in limited circumstances, the MHRA may consider an enhanced non-clinical assessment, including for first-in-human trials in patients with advanced cancers or other serious or life-threatening conditions where there is significant unmet medical need. This provides additional scientific scrutiny of the available evidence where appropriate. Alongside the assessment of individual applications, the MHRA will undertake a strategic, risk-based programme of inspections of non-clinical test facilities that are frequently identified in clinical trial applications submitted to the UK. This will help inform future regulatory assessments and support a proportionate, evidence-based approach to regulatory oversight. The guidance does not change the standards expected for the quality, safety or integrity of pivotal non-clinical safety data. It provides greater clarity on how the MHRA will assess available evidence and apply proportionate regulatory scrutiny to individual applications. The MHRA’s approach will evolve in line with regulatory experience, compliance intelligence and outcomes from test facility inspections. Developers planning to use non-clinical data generated outside the OECD Mutual Acceptance of Data system are encouraged to engage early before submitting a clinical trial application. For more information, read Use of non-OECD MAD non-clinical data in support of UK clinical trial authorisation applications - GOV.UK