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The Medicines and Medical Devices Act 2021 imposes a statutory duty on the MHRA to "take all reasonable steps to promote the use of non-animal methods of testing where possible" when assessing medicines. More than four years after this duty became law, the MHRA appears to have produced no standalone documents, policy papers, specific guidance, handbooks, or public roadmaps under its own name on this topic. Instead, any related activities seem embedded within the Department for Science, Innovation and Technology (DSIT)-led cross-government strategy for 2025, without MHRA-specific leadership or outputs. This stands in stark contrast to the approaches of comparable international regulators: The U.S. Food and Drug Administration (FDA) has demonstrated proactive leadership, including a dedicated 2025 Roadmap for New Alternative Methods Program, standalone guidance on NAMs (e.g., December 2025 draft on streamlined NHP tox), immediate encouragement in submissions (e.g., INDs; NAMs as encouraged/default in phases), metrics, workshops, qualification pathways, and published use cases, metrics, and coordinating committees. The European Medicines Agency (EMA) in the EU has also shown strong commitment, with dedicated NAMs/3Rs web sections and papers (e.g., ethical use pages, reflection papers, concept papers on 3Rs/NAMs), standalone guidance/reflection papers on NAMs (e.g., 2024/2025 papers on testing requirements, NHPs, 3Rs), early dialogue mechanisms (e.g., Innovation Task Force, Scientific Advice, horizon scanning), a robust legal foundation under EU Directive 2010/63/EU (mandating 3Rs with ultimate replacement goals), proactive fostering of acceptance and experience-building, and ongoing key actions (e.g., reflection papers 2024-2025). In light of the MHRA's legal obligations and the evident disparities with the FDA and EMA, please provide the following information: 1. All internal documents, plans, roadmaps, or strategies developed by the MHRA (whether standalone or in collaboration) that outline specific steps, timelines, and milestones for promoting and implementing non-animal methods (NAMs) in the assessment of medicines, including any acceptance criteria, guidance for developers, or qualification pathways. If no such documents exist, please confirm this and explain why, given the statutory duty under the Medicines and Medical Devices Act 2021. 2. Details of any public or internal roadmaps, policy papers, guidance documents, handbooks, workshops, metrics, or use cases produced by the MHRA specifically on NAMs since the enactment of the Medicines and Medical Devices Act 2021. If none have been produced under the MHRA's name, please provide the rationale for relying solely on the DSIT-led cross-government strategy and how this fulfills the MHRA's independent statutory responsibilities. 3.Records of any communications, meetings, or consultations between the MHRA and stakeholders (e.g., developers, industry groups, or animal welfare organizations) regarding the promotion of NAMs, including pre-submission advice mechanisms, developer-led case-by-case approaches, or international alignments (e.g., with ICH/OECD). 4. Any assessments or evaluations conducted by the MHRA comparing its approach to NAMs with that of the FDA and EMA, including explanations for differences in leadership style (e.g., proactive vs. facilitative), transparency/outputs, and timelines for key actions (e.g., many 2026 milestones for MHRA vs. ongoing 2024-2025 actions for EMA). If no such comparisons exist, please confirm and provide the MHRA's position on these international benchmarks. 5. Information on any future commitments or plans by the MHRA to address gaps in standalone leadership on NAMs, such as developing dedicated guidance, public roadmaps, or formalized mechanisms for early dialogue and acceptance, in line with its legal duties.
Published: 2 February 2026
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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.
Published: 2 February 2026
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Please could I request a copy of the current registered RMP for Cialis Together 10 mg film-coated tablets
Published: 2 February 2026
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Please provide me with any documents, internal and external communications and other information relating to the 2001 approval of Sustanon 250 for the treatment of female to male transsexualism.
Published: 2 February 2026
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I attach letter dated 12 December 2025 from UKHSA in reply to my request for information. The content should be self-explanatory. I would be grateful if you could arrange to provide me with the following information from MHRA records. 1. Details of the approved diagnostic test for Influenza [Flu], and 2. Details of the approved diagnostic test for Covid 19.
Published: 2 February 2026
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Is it possible to request the SAEs that have been reported for a current drug trial being carried out byAstra Zeneca? Official Study Title: A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination with Carboplatin plus Pemetrexed Versus Platinum plus Pemetrexed or Nivolumab plus Ipilimumab in Participants with Unresectable Pleural Mesothelioma (eVOLVE-Meso) Study number: D7988C00001 Product name: Volrustomig (MEDI5752)
Published: 2 February 2026
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I have to FOI Requests for documents originating from when MHRA was Rapporteur for Pomalidomide. NUMBER 1) 1.1. Major objections THIS DOCUMENT WILL BE FIND IN: Rapporteurs' Day 150 Joint Response Assessment Report Clinical - Assessment of the responses to the CHMP List of Questions Pomalidomide Celgene EMEA/H/C/2682 1. Assessment of the responses to the CHMP List of Questions - Clinical aspects NUMBER 2) 1.1. Major objections THIS DOCUMENT WILL BE FIND IN: Rapporteurs' Day 180 Joint Response Assessment Report Clinical - Assessment of the responses to the CHMP List of Questions Pomalidomide Celgene EMEA/H/C/2682 1. Assessment of the responses to the CHMP List of Questions - Clinical aspects
Published: 2 February 2026
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Due to the hypertonicity of 50% glucose, it is known that phlebitis and the like can occur.I am trying to review the use of this product within our trust and suggesting safer alternatives forhyperkalaemia.Do you have any data/numbers/reports on this please? A clinician is asking for any local, nationaldata to support or refute the need to change
Published: 2 February 2026
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Can you please send me the inspection reports for Great Bear Distribution Limited that were conducted and recorded below please: UK WDA(H) 34866 Insp GDP 34866/15862148-0004 GREAT BEAR DISTRIBUTION LIMITED, COLIN MCDAVID WAY, 59 MARKHAM LANE, DUCKMANTON, CHESTERFIELD, S44 5HY, UNITED KINGDOM UNITED KINGDOM Inspection Date 20/10/2021 ------------------------------------------------------------------------------------------------ UK WDA(H) 34866 Insp GDP 34866/3009693-0005 GREAT BEAR DISTRIBUTION LIMITED, 78-79 SALTHOUSE ROAD, BRACKMILLS INDUSTRIAL ESTATE, NORTHAMPTON, NN4 7EX, UNITED KINGDOM Inspection Date 06/11/2018 In addition can you confirm whether an inspection has ever been conducted at: GREAT BEAR DISTRIBUTION LIMITED, UNIT 2, NOOK FLATT ROAD, BLYTH, WORKSOP, S81 8GN If an inspection has been completed, but no GDP certificate issued, can I also have a copy of that report and a statement as to why no certificate issued.
Published: 2 February 2026
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Published: 2 February 2026
