使用非OECD MAD非临床数据支持英国临床试验授权申请
正文 · 中文译文
指南 使用非OECD MAD非临床数据支持英国临床试验授权申请 MHRA关于使用在OECD MAD框架之外产生的非临床数据以支持英国临床试验授权申请的指南。 来自： 药品和保健产品监管局 发布时间： 2026年11月4日 获取有关此页面的电子邮件 打印此页面 目录 1. 引言和范围 2. 一般原则 3. MHRA非OECD MAD数据框架 4. 检查与合规情报流 5. 增强的非临床评估路径 6. 临床数据的权重证据应用 7. 框架的未来演变 附件A：关键概念和评估原则 1. MHRA为何引入此框架 2. 非OECD MAD数据的定义 3. 在增强非临床评估流之外使用检查信息 4. MHRA检查与GLP合规状态 5. 获取和使用检查声明 6. 使用其他监管机构的检查发现 7. 非OECD MAD数据的额外信息要求 8. 非OECD MAD数据的可接受性 9. 肿瘤试验对增强非临床评估流的资格 10. 晚期肿瘤的定义 11. 危及生命和严重衰弱状况的定义 12. 重大未满足医疗需求的定义 13. 增强非临床评估流的资格 14. 关于资格的提交前建议 15. 使用既往MHRA科学建议 16. 未确认增强非临床评估流（enhanced non-clinical assessment stream）资格的情形 17. 资格确认与非临床数据的可接受性 18. 经合组织（OECD）MAD与非OECD MAD混合非临床研究套件的评估 19. 临床数据在弥补非临床数据套件缺陷中的作用 20. 附加及英国特定的临床试验保障措施 21. 在未來申请中使用先前已接受的非OECD MAD数据 22. 桥接方法（bridging approach）的定义 23. 种族与人群差异对临床试验申请（CTA）评估的相关性 24. 评估种族与人群差异的证据要求 25. 支持临床数据适用于英国试验人群的证据 附录B：案例研究 1. 引言与范围 引言 经济合作与发展组织（OECD）数据互认（MAD）框架以良好实验室规范（GLP）原则为基础，仍是关键非临床安全性数据生成与监管接受的国际公认标准。在OECD MAD框架内生成的数据受益于既有的合规监测计划，并为决策提供高水平的监管信心。 MHRA认识到，非临床药物开发日益全球化的性质导致更多使用专业检测设施，在OECD MAD框架之外产生非临床数据。这些非临床开发项目中有许多支持旨在应对严重疾病、罕见病症和重大未满足患者需求领域的创新药物。 MHRA致力于支持患者及时获得创新药物，并在英国促成高质量临床研究，同时维持参与者保护和科学诚信的严格标准。为支持这些目标，MHRA已建立一个风险相称且以患者为中心的框架，用于审议为支持临床试验授权（CTA）申请而提交的非OECD MAD非临床数据。 就本指南而言，“非OECD MAD数据”指不属于OECD数据相互接受体系强制接受安排范围内的非临床数据。这包括： 在既非OECD成员国亦非OECD MAD完全遵守国的国家产生的数据 在未被OECD MAD体系下认可的国家GLP合规监测计划覆盖、或其GLP合规状态未经该计划核实的检测设施或检测场所产生的数据 在OECD MAD体系下，非临床安全性数据的强制接受不仅取决于工作开展所在国家，还取决于检测设施及任何相关检测场所的GLP合规状态。 在本指南的适用范围内，若实验室未被纳入相关国家良好实验室规范（GLP）符合性监督计划的范围，或其GLP符合性状态未经相关GLP监督机构验证，则在位于经济合作与发展组织（OECD）成员国或完全遵守相互数据接受（MAD）国家的实验室所产生的数据，仍可被视为非OECD MAD数据。同样，在位于OECD成员国或完全遵守MAD国家之外的实验室所产生的数据，无论该实验室是否经过其他机构的检查，均不被视为属于OECD MAD框架的范围。 一项不属于OECD MAD框架的研究，可能是按照OECD GLP原则或适用的当地GLP要求进行的。然而，通过OECD MAD体系提供的监管保证依赖于研究是在受其所在国家国家GLP符合性监督计划约束的试验机构或试验场地进行的。若不符合此条件，则与OECD MAD相关的保证不适用。GLP符合性的声明或主张不提供同等的保证。 该框架旨在在适当情况下促进有前景的新药研发，同时确保与非OECD MAD数据相关的任何不确定性得到识别、理解和管理。本指南阐述了MHRA的初步方法。该框架将接受持续审查，并在有新出现的证据和监管经验支持的情况下，可能扩展至涵盖更广泛的治疗领域、试验阶段或临床开发环境。随着通过CTA评估、检查和合规情报活动、利益相关方参与以及更广泛监管保证活动积累经验，该框架也可能进一步完善。 MHRA的方法包括三个互补且相互关联的流程，共同支持监管决策的不同方面。这些流程提供不同但相互增强的保证来源，可根据数据包的性质和监管不确定性的程度单独或组合应用。每个流程的进一步细节见下文。 范围 本指南的范围是： 描述MHRA在接受和使用OECD MAD体系之外生成的非临床数据以支持CTA申请方面的方法 就申办者在依赖非OECD MAD数据时应提交的信息提供透明度和指导 描述检查和合规情报活动如何随着时间的推移有助于增强对非OECD MAD数据的监管信心 说明符合条件的申请可据此被考虑授予许可的增强评估路径 概述在适当情况下如何在证据权重框架内考虑临床数据 支持一致、透明且相称的监管决策，同时维护参与者安全 本指南广泛适用于依赖在OECD MAD框架之外生成的非临床数据的CTA申请。然而，增强非临床评估路径的资格仅限于符合第5.0节所列标准的申请。 不符合这些标准的申请仍可通过标准CTA途径提交，非OECD MAD数据将根据具体情况进行考虑。该框架的其他要素，包括检查和合规情报活动以及证据权重考量，可根据申请的具体情况更广泛地适用。 2. 一般原则 申办者应注意，按照OECD GLP开展并受OECD MAD体系覆盖的研究仍是关键非临床安全性研究的主要和预期标准。 本框架下的评估将遵循以下原则： 参与者安全始终至高无上 决策将基于现有全部证据 所适用的审查力度将与不确定性程度及数据对监管决策的重要性相称 预期的患者获益和未被满足的医疗需求将在整体获益-风险评估中予以考虑 参与OECD MAD框架是保证的重要来源，但并非信心的唯一决定因素。信心还将基于与相关研究和试验设施有关的现有证据、检查与合规情报以及积累的监管经验。 3. MHRA非OECD MAD数据框架 MHRA对非OECD MAD非临床数据的考量框架由三个互补且相互关联的流组成： 检查与合规情报 强化非临床评估 临床数据的证据权重应用 这些流旨在作为一个协调框架运作，而非独立的监管路径。根据申请的具体情况，一个或多个流可能对整体监管评估作出贡献。每个流的相对贡献将取决于多种因素，包括研究用药品（IMP）的性质、对非OECD MAD数据的依赖程度、现有证据相关的不确定性水平以及对参与者安全的潜在影响。 检查与合规情报流是该框架的一个较长期战略组成部分。它通过检查活动、合规情报和积累的监管经验，支持监管机构逐步建立对在OECD MAD框架之外生成非临床数据的特定试验机构的监管信心。随着信心的建立，该流可支持对这些机构所生成数据的评估采取更为相称的方法，包括对不符合增强非临床评估流资格标准的申请。 增强非临床评估流提供了一条即时途径，使符合条件的申请可在MHRA检查与合规情报能力持续发展的同时得到考虑。从较长期来看，该流对于依赖尚未建立充分MHRA检查与合规情报的机构数据的符合条件的申请仍将具有相关性。在此类情况下，与非OECD MAD数据相关的不确定性将得到适当的表征和管理。 临床数据证据权重使用流使得相关的既往人体经验（在可获得且适当时）能够与非临床及其他支持性证据一并作为整体监管评估的一部分加以考虑。 随着时间的推移，检查结果、合规情报和积累的监管经验可能会增强监管机构对特定设施的研究实施、质量体系和数据完整性的信心。在已建立充分信心的情况下，由这些设施生成的数据支持的CTA申请可通过标准CTA流程进行评估，而无需按照增强非临床评估流通常预期的额外信息。此类申请仍将遵循常规的科学和监管评估要求。 4. 检查与合规情报流 目的 检查与合规情报流支持对生成非临床数据以支持英国CTA申请的非OECD MAD设施建立监管信心。 该流的目标是增强MHRA对选定设施所使用的系统、流程和控制措施的了解，并支持对在OECD MAD框架之外生成的数据的可靠性、完整性和可追溯性进行评估。通过该流获得的信息可为当前和未来的监管决策提供依据。 该流是MHRA审理非OECD MAD数据的更广泛框架的一部分，并与增强非临床评估流和证据权重流相辅相成。 检查与合规情报活动 为支持这些目标，MHRA将对选定设施开展有针对性的、基于风险的检查，并可能考虑其他相关合规情报来源。 设施将被选为检查对象，主要依据是该设施生成的数据提交用于支持英国CTA申请的频率。检查的安排和范围还将考虑这些数据对监管决策的重要性、任何新出现的合规情报以及监管不确定性的性质和程度。设施可通过审查CTA申请及相关监管信息予以确定。检查是MHRA更广泛合规情报战略的一部分，并不必然构成对某一特定CTA或研究的定向检查。 任何检查将由英国良好实验室规范监督机构（UK GLPMA）实施。这些活动将在自愿基础上进行，不构成法定GLP合规监督检査，且不会导致签发UK GLPMA GLP合规证书。检查可能包括审查： 生成关键性非OECD MAD非临床数据的设施 质量管理体系 研究数据和支持性记录 数据处理、可追溯性和归档安排 每次检查的范围和深度将采用基于风险的方法确定，可能包括设施层面的系统、相关流程和选定研究，目的是评估现有安排是否能为该设施所生成数据的可靠性、完整性和可追溯性提供充分信心。 检查结束后，受检试验设施应针对任何检查发现作出回应，并提供适当的纠正和预防措施计划。英国GLP监测机构（UK GLPMA）可要求提供实施或完成的证据，同时考虑检查发现的性质和严重程度。 在检查流程结束后，将出具检查声明，而非GLP合规声明。结束基于英国GLP监测机构对设施针对检查发现的回应（包括拟议的纠正和预防措施）的审查和接受。接受回应并不一定要求在所有措施完成后方可结束。检查声明将描述检查的范围和结果，并说明设施对检查发现的回应是否已被UK GLPMA接受。MHRA还可酌情考虑来自监管机构和可信来源的相关检查发现及其他合规信息（在可获得且适当的情况下）。此类信息的相关性和权重将结合其范围及对相关设施和研究的适用性加以考虑。 MHRA将继续考虑是否可以以及以何种形式传达有关受检设施、检查结果和合规情报活动的信息，以支持透明度、监管信心和适当的保密保护。 申办者责任 当申办者直接委托研究时，与试验设施签订的合同安排应包含允许与MHRA适当接触的条款，包括在需要检查或其他合规活动时与英国GLPMA接触。这些条款应使试验设施能够回应信息请求，提供相关研究数据和支持性记录的访问权限，并在必要时促进监管检查活动。 申办者应在其相称的尽职调查中，请求获取有关该设施质量体系、监管监督和相关检查历史的现有信息。如有检查声明，申办者应请求并审阅该声明，同时考虑检查的范围、时间和结果及其与拟用于支持CTA的研究的相关性。申办者应考虑现有信息是否对所生成数据的可靠性、完整性和可追溯性提供了足够的信心，并在提交材料中描述任何相关局限性或残余不确定性。 MHRA认识到，申办者并非总是与产生原始非临床数据的设施有直接的合同关系，尤其是在产品被收购或引进许可的情况下。在此类情况下，申办者应提供可获得的信息，并解释在获取支持性文件方面存在的任何限制。相关期望将按比例适用，并结合申办者合理可获得的信息来考量。 对监管信心的贡献 检查结果及其他相关合规情报可有助于MHRA对某试验设施的信心水平，并在适当情况下支持对该设施所产生数据的评估采取更为相称的方式。然而，MHRA的检查并不授予GLP合规地位，也不保证接受在该设施产生的数据。单个研究的可接受性仍将取决于对s的评估
正文 · 英文原文
Guidance Use of non-OECD MAD non-clinical data in support of UK clinical trial authorisation applications MHRA guidance on the use of non-clinical data generated outside the OECD MAD framework in support of UK Clinical Trial Authorisation applications. From: Medicines and Healthcare products Regulatory Agency Published: 4 November 2026 Get emails about this page Print this page Contents 1. Introduction and scope 2. General principles 3. MHRA Framework for non-OECD MAD data 4. Inspection and compliance intelligence stream 5. Enhanced non-clinical assessment pathway 6. Weight-of-evidence use of clinical data 7. Future evolution of the framework Annex A: key concepts and assessment principles 1. Why the MHRA has introduced this framework 2. Definition of non-OECD MAD data 3. Use of inspection information outside the enhanced non-clinical assessment stream 4. MHRA inspections and GLP compliance status 5. Obtaining and using statements of inspection 6. Use of inspection findings from other regulatory authorities 7. Additional information requirements for non-OECD MAD data 8. Acceptability of non-OECD MAD data 9. Eligibility of oncology trials for the enhanced non-clinical assessment stream 10. Definition of advanced oncology 11. Definitions of life-threatening and severely debilitating conditions 12. Definition of substantial unmet medical need 13. Eligibility for the enhanced non-clinical assessment stream 14. Pre-submission advice on eligibility 15. Use of previous MHRA scientific advice 16. Where eligibility for the enhanced non-clinical assessment stream is not confirmed 17. Eligibility confirmation and acceptance of non-clinical data 18. Assessment of mixed OECD MAD and non-OECD MAD non-clinical study packages 19. Role of clinical data in addressing deficiencies in the non-clinical package 20. Additional and UK-specific clinical trial safeguards 21. Use of previously accepted non-OECD MAD data in future applications 22. Definition of a bridging approach 23. Relevance of ethnic and population differences to CTA assessment 24. Evidence requirements for assessing ethnic and population differences 25. Evidence supporting the applicability of clinical data to the UK trial population Annex B: case studies 1. Introduction and scope Introduction The Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) framework, underpinned by the principles of good laboratory practice (GLP), remains the internationally recognised standard for the generation and regulatory acceptance of pivotal non-clinical safety data. Data generated within the OECD MAD framework benefit from established compliance monitoring programmes and provide a high level of regulatory confidence for decision-making. The MHRA recognises that the increasingly global nature of non-clinical drug development has led to greater use of specialist test facilities generating non-clinical data outside the OECD MAD framework. Many of these non-clinical development programmes support innovative medicines intended to address serious diseases, rare conditions, and areas of significant unmet patient need. The MHRA is committed to supporting timely patient access to innovative medicines and enabling high-quality clinical research in the UK, while maintaining robust standards of participant protection and scientific integrity. To support these objectives, the MHRA has established a risk-proportionate and patient-centred framework for the consideration of non-OECD MAD non-clinical data submitted in support of clinical trial authorisation (CTA) applications. For the purposes of this guidance, “non-OECD MAD data” refers to non-clinical data that do not fall within the mandatory acceptance arrangements of the OECD mutual acceptance of data system. This includes: data generated in countries that are neither OECD members nor full adherents to OECD MAD data generated at test facilities or test sites that are not covered by, or whose GLP compliance status has not been verified through, a national GLP compliance monitoring programme recognised under the OECD MAD system Under the OECD MAD system, mandatory acceptance of non-clinical safety data depends not only on the country in which the work was conducted but also on the GLP compliance status of the test facility and any relevant test sites. Data generated at a laboratory located within an OECD member country or full MAD adherent country may still be considered non-OECD MAD data for the purposes of this guidance where the laboratory is not included within the scope of the relevant national GLP compliance monitoring programme, or where its GLP compliance status has not been verified by the relevant GLP monitoring authority. Similarly, data generated at a laboratory located outside an OECD member country or full MAD adherent country are not considered to fall within the OECD MAD framework, irrespective of whether the laboratory has been inspected by another authority. A study falling outside the OECD MAD framework may have been conducted in accordance with OECD GLP principles or applicable local GLP requirements. However, the regulatory assurance provided through the OECD MAD system relies on the study having been conducted at a test facility or test site that is subject to the national GLP compliance monitoring programme of the country in which it is located. Where this condition is not met, the assurances associated with OECD MAD do not apply. A statement or claim of GLP compliance does not provide equivalent assurance. The framework is intended to facilitate the development of promising new medicines where appropriate, while ensuring that any uncertainty associated with non-OECD MAD data is identified, understood, and managed. This guidance sets out the MHRA’s initial approach. The framework will be kept under review and, where supported by emerging evidence and regulatory experience, may be expanded to encompass a broader range of therapeutic areas, trial phases or clinical development settings. The framework may also be refined as experience is gained through CTA assessments, inspection and compliance intelligence activities, stakeholder engagement and wider regulatory assurance activities. The MHRA approach comprises three complementary and interconnected streams that together support different aspects of regulatory decision-making. The streams provide different but mutually reinforcing sources of assurance and may be applied individually or in combination, depending on the nature of the data package and the level of regulatory uncertainty. Further details of each stream are provided below. Scope The scope of this guidance is to: describe the MHRA’s approach to the acceptance and use of non-clinical data generated outside the OECD MAD system in support of CTA applications provide transparency and guidance regarding the information sponsors should submit when relying on non-OECD MAD data describe how inspection and compliance intelligence activities may contribute to regulatory confidence in non-OECD MAD data over time explain the enhanced assessment pathway through which eligible applications may be considered for authorisation outline how clinical data may be considered within a weight-of-evidence framework where appropriate support consistent, transparent, and proportionate regulatory decision-making while maintaining participant safety This guidance applies broadly to CTA applications that rely on non-clinical data generated outside the OECD MAD framework. However, eligibility for the Enhanced Non-Clinical Assessment Pathway is limited to applications meeting the criteria set out in Section 5.0. Applications that do not meet those criteria may still be submitted through the standard CTA route, and non-OECD MAD data will be considered on a case-by-case basis. Other elements of the framework, including inspection and compliance intelligence activities and weight-of-evidence considerations, may apply more broadly depending on the circumstances of the application. 2. General principles Sponsors should note that studies conducted in accordance with OECD GLP and covered by the OECD MAD system remain the primary and expected standard for pivotal non-clinical safety studies. Assessment under this framework will be guided by the following principles: participant safety remains paramount decisions will be informed by the totality of evidence available the level of scrutiny applied will be proportionate to the degree of uncertainty and the importance of the data for regulatory decision-making the anticipated patient benefit and unmet medical need will be considered within the overall benefit-risk assessment Participation in the OECD MAD framework represents an important source of assurance but is not the sole determinant of confidence. Confidence will also be informed by the available evidence relating to the relevant studies and test facilities, inspection and compliance intelligence, and accumulated regulatory experience. 3. MHRA Framework for non-OECD MAD data The MHRA framework for the consideration of non-OECD MAD non-clinical data comprises three complementary and interconnected streams: inspection and compliance intelligence enhanced non-clinical assessment weight-of-evidence use of clinical data The streams are intended to operate as a coordinated framework rather than as independent regulatory pathways. Depending on the specific circumstances of an application, one or more streams may contribute to the overall regulatory assessment. The relative contribution of each stream will depend on factors including the nature of the investigational medicinal product (IMP), the extent of reliance on non-OECD MAD data, the level of uncertainty associated with the available evidence, and the potential implications for participant safety. The inspection and compliance intelligence stream represents a longer-term strategic component of the framework. It supports the progressive development of regulatory confidence in selected test facilities generating non-clinical data outside the OECD MAD framework through inspection activities, compliance intelligence and accumulated regulatory experience. As confidence develops, this stream may support a more proportionate approach to the assessment of data generated at those facilities, including for applications that do not meet the eligibility criteria for the enhanced non-clinical assessment stream. The enhanced non-clinical assessment stream provides an immediate route through which eligible applications may be considered while MHRA inspection and compliance intelligence capability continues to develop. The stream will also remain relevant over the longer term for eligible applications relying on data from facilities for which sufficient MHRA inspection and compliance intelligence has not been established. In such cases, uncertainty associated with the non-OECD MAD data will be appropriately characterised and managed. The Weight-of-Evidence Use of Clinical Data Stream enables relevant prior human experience, where available and appropriate, to be considered, alongside non-clinical and other supporting evidence as part of the overall regulatory assessment. Over time, inspection outcomes, compliance intelligence, and accumulated regulatory experience may increase regulatory confidence in study conduct, quality systems, and data integrity at specific facilities. Where sufficient confidence has been established, CTA applications supported by data generated at those facilities may be assessed through standard CTA processes without the additional information normally expected under the enhanced non-clinical assessment stream. Such applications will remain subject to the usual scientific and regulatory assessment requirements. 4. Inspection and compliance intelligence stream Purpose The Inspection and Compliance Intelligence Stream supports the development of regulatory confidence in non-OECD MAD facilities that generate non-clinical data submitted in support of UK CTA applications. The objective of this stream is to enhance MHRA understanding of the systems, processes, and controls used by selected facilities and to support assessment of the reliability, integrity, and traceability of data generated outside the OECD MAD framework. Information obtained through this stream may contribute to both current and future regulatory decision-making. This stream forms part of the broader MHRA framework for the consideration of non-OECD MAD data and complements the Enhanced Non-Clinical Assessment and Weight-of-Evidence streams. Inspection and compliance intelligence activities To support these objectives, the MHRA will undertake targeted, risk-based inspections of selected facilities and may consider other relevant sources of compliance intelligence. Facilities will be selected for inspection primarily based on the frequency with which data generated at the facility are submitted in support of UK CTA applications. The scheduling and scope of inspections will also take account of the importance of those data to regulatory decision-making, any emerging compliance intelligence, and the nature and level of regulatory uncertainty. Facilities may be identified through review of CTA applications and associated regulatory information. Inspections form part of the MHRA’s broader compliance intelligence strategy and will not necessarily constitute a directed inspection of a particular CTA or study. Any inspections will be undertaken by the UK Good Laboratory Practice Monitoring Authority (UK GLPMA). These activities will be conducted on a voluntary basis, do not constitute statutory GLP compliance monitoring inspections and will not result in the issuance of a UK GLPMA GLP compliance certificate. They may include review of: facilities generating pivotal non-OECD MAD non-clinical data quality management systems study data and supporting records data handling, traceability, and archiving arrangements The scope and depth of each inspection will be determined using a risk-based approach and may include facility-level systems, relevant processes and selected studies, with the objective of evaluating whether the arrangements in place provide sufficient confidence in the reliability, integrity and traceability of data generated at the facility. Following the inspection, the test facility will be expected to respond to any findings and provide appropriate corrective and preventive action plans. The UK GLPMA may request evidence of implementation or completion, taking account of the nature and significance of the findings. A statement of inspection, rather than a GLP statement of compliance, will be issued once the inspection process has been closed. Closure is based on the UK GLP Monitoring Authority’s review and acceptance of the facility’s response to the inspection findings, including proposed corrective and preventive actions. Acceptance of the response does not necessarily require completion of all actions before closure. The Statement of Inspection will describe the scope and outcome of the inspection and indicate whether the facility’s response to the inspection findings was accepted by the UK GLPMA. The MHRA may also consider relevant inspection findings and other compliance information from regulatory authorities and trusted sources, where available and appropriate. The relevance and weight of such information will be considered in the context of its scope and applicability to the facility and studies concerned. The MHRA will continue to consider whether, and in what form information about facilities inspected and the outcomes of inspection and compliance intelligence activities may be communicated to support transparency and regulatory confidence and appropriate confidentiality protections. Sponsor responsibilities Where sponsors directly commission studies, contractual arrangements with test facilities should include provisions permitting appropriate engagement with the MHRA, including the UK GLPMA where inspection or other compliance activities are required. These provisions should enable the test facility to respond to requests for information, provide access to relevant study data and supporting records and facilitate regulatory inspection activities where necessary. Sponsors should request available information concerning the facility’s quality systems, regulatory oversight and relevant inspection history as part of their proportionate due diligence. Where an inspection statement is available, sponsors should request and review it, taking account of the scope, timing and outcome of the inspection and its relevance to the studies intended to support the CTA. Sponsors should consider whether the information available provides sufficient confidence in the reliability, integrity and traceability of the data generated, and describe in the submission any relevant limitations or residual uncertainties. The MHRA recognises that sponsors may not always have direct contractual relationships with facilities that generated the original non-clinical data, particularly where products have been acquired or in-licensed. In such circumstances, sponsors should provide available information and explain any limitations on access to supporting documentation. Expectations will be applied proportionately and in the context of information reasonably available to the sponsor. Contribution to regulatory confidence Inspection outcomes and other relevant compliance intelligence may inform the MHRA’s level of confidence in a test facility and, where appropriate, support a more proportionate approach to the assessment of data generated at that facility. However, an MHRA inspection does not confer GLP compliance status or guarantee acceptance of data generated there. The acceptability of an individual study will remain subject to assessment of the s