FOI release
MHRA Plans for Promoting Non-Animal Methods (NAMs) in Medicines Assessment
Some or all of the information requested may not have been provided because we determined that the request was vexatious.
Case reference FOI2026/00050
Received 19 January 2026
Published 2 February 2026
Request
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.
Response
See attached
Documents
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