FOI release
Freedom of Information request: MHRA expertise and capacity in New Approach Methodologies
Some or all of the information requested may not have been provided because we determined that the request was vexatious.
Case reference FOI2026/00032
Received 14 January 2026
Published 2 February 2026
Request
Under the Freedom of Information Act 2000, please provide the following information relating to the MHRA's expertise, capacity, and processes for evaluating and accepting New Approach Methodologies (NAMs) / non-animal alternatives in medicines regulation, including safety assessments, toxicology, and batch testing. As the UK's regulator with legal functions under the Human Medicines Regulations 2012, the MHRA must ensure safe and accurate regulatory judgments, particularly where NAMs replace or reduce animal testing under the 3Rs principles. This request focuses on key regulatory features of advanced NAMs frameworks (e.g., tiered structures from exposure-based waiving and in silico predictions to advanced bioactivity screening and IVIVE via PBK modeling; weight-of-evidence integration that is AOP-informed with uncertainty characterization; visual decision flowcharts for usability; and implementation roadmaps including short-term pilots, training, and harmonization with bodies like FDA, ECHA, and OECD). It also highlights specific advanced NAMs, such as: In silico methods (e.g., QSAR, machine learning, read-across) for initial screening (e.g., genotoxicity, skin sensitization). Adverse Outcome Pathways (AOP) and Integrated Approaches to Testing and Assessment (IATA) for data combination. Liver-on-chip and 3D hepatic spheroids for predicting drug-induced liver injury (DILI). Other cell-based assays (e.g., T-cell activation, tissue cross-reactivity) for biotherapeutics. 1. If MHRA expertise or experience in these areas is limited, please explain how the agency ensures safe and accurate regulatory judgments (e.g., in accepting NAMs data for marketing authorisations, clinical trials, or batch releases). 2. Details of current in-house expertise and skills in the above NAMs and regulatory frameworks. This includes: Approximate number of staff/assessors with specialist knowledge or training in these methods (e.g., proportion experienced in evaluating AOP/IATA, in silico tools, organ-on-chip models, or IVIVE/PBK). Any dedicated teams, roles, or working groups focused on NAMs integration into regulatory processes. Evidence of expertise in key features like tiered structures, weight-of-evidence with uncertainty characterization, decision flowcharts, or harmonization efforts. 3. Any internal assessments, reports, audits, gap analyses, or training needs analyses (from 2020 onwards) identifying deficiencies, skill gaps, capacity constraints, or risks in MHRA's ability to evaluate NAMs data safely and accurately for regulatory decisions. 4. Actions taken or planned to address any identified gaps in NAMs expertise and capacity, ensuring robust regulatory judgments. Please include: Training programmes, courses, workshops, or certifications (with dates and numbers of staff involved since November 2025). Recruitment, secondments, external hires, or partnerships (e.g., with NC3Rs, FDA, EMA, OECD) for building capability. Funding allocations or resources for upskilling in NAMs. 5. Any internal guidance, standard operating procedures, decision flowcharts, or metrics for assessing NAMs submissions and characterizing uncertainty. 6. Progress made to date against MHRA commitments in the November 2025 "Replacing animals in science" strategy related to NAMs expertise (e.g., new guidelines by end-2026 for non-animal data in First-in-Human studies; biennial statements on acceptable alternatives; joining the International Medicines Regulators' Working Group on 3Rs; or pilots for advanced NAMs like liver-on-chip). If any part exceeds the cost limit, please advise what can be provided or suggest refinements. I prefer electronic format.
Response
See attached
Documents
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