2025 was a year of immense progress for non-animal models globally. Read Dr Natalie Anderson’s summary, reflecting on Australian and international highlights.
Global Landscape
The pace accelerated in 2025 for NAMs, bringing some massive shifts globally. The US released their Landmark Roadmap to Reducing Animal Testing in Preclinical Safety Studies, and a US FDA / National Institutes of Health joint workshop was held in July discussing progress and future activities, including the launch of the Office of Research Innovation, Validation, and Application (ORIVA) and associated funding scheme (44 Million USD). ORIVA is intended to “coordinate NIH-wide efforts to develop, validate, and scale the use of non-animal approaches across the agency’s biomedical research portfolio and serve as a hub for interagency coordination and regulatory translation for public health protection”.
In Europe a European Chemicals Agency workshop was held in June 2025 discussing the 2026 Q1 release of their Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments. In November 2025 the UK announced their Policy paper Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods and 75 million GDP in funding to support these endeavours with the establishment of a UK Centre for the Validation of Alternative Methods (UKCVAM).
Building on The FDA Modernization Act 2.0, The FDA Modernization Act 3.0 was introduced on the 3rd February 2025 and passed the Senate on the 16th December 2025: “This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug”.
In July 2025 Environment and Climate Change Canada and Health Canada released their Strategy to Replace, Reduce or Refine Vertebrate Animal Testing under the Canadian Environmental Protection Act however it requires follow up with funding and timelines for phasing out animal use. Announced in May 2025, a dedicated animal-free testing facility will be built in Incheon, South Korea, for completion in October 2026. South Korea will also host the 14th World Congress on Alternatives and Animal Use in the Life Sciences in 2027 and has a national goal for a 60% reduction in animal toxicity testing by 2030 outlined in the 2030 Chemical Safety and Animal Welfare vision.
Landmark Drug Approvals
In November the US FDA approved an investigational new drug for clinical trials with efficacy data generated solely from non-animal models. This example joins a growing list of Examples of drugs or therapeutics approved or advanced to clinical trials with limited reliance on animal test data, collated by AFSA.
Focus on Primates
In the US, several landmark decisions were made regarding discontinuing the use of non-human primates (NHPs):
- April 2025: The US FDA focuses on phasing out of NHP studies in the Roadmap
- November 2025: The Centre for Disease control was ordered to cease all current and future projects involving primates
In the Netherlands, the Senate voted to phase out public funding for primate experiments at the Biomedical Primate Research Centre (BPRC) in Rijswijk, the largest primate research facility in Europe.
The UK strategy sets a target to reduce primate by 35% by 2030 for medicine testing.
AFSA advocates for an end to primate experiment in Australia, with a call to end extend the current prohibition on using great apes to all primate species.
Australian Landscape
Funding
In Australia, the pace was much slower than our global colleagues and disappointingly no significant action was taken to support the recommendations of the CSIRO report, with most of the progress coming independently from industry, academia and not-for-profits (NSW NAT-Net, AFSA, Medical Advances without Animals and Bellberry). Despite the lack of support for funding nationally, the NSW Non-animal technology Network released their grant funding round with a total of 600,000 AUD of competitive funding available for 3 projects (200,000 AUD each) funded through the NSW Government as a result of the parliamentary inquiry in 2021. Phenomics AU received a funding boost of 7.2 million AUD to the 5 million AUD investment in 2021, through the Department of Education National Collaborative Research Infrastructure Strategy scheme. Phenomics AU continue to provide services for both NAMs and animal models.
Legislation and Policy
The policy environment showed some incremental improvements which are foundational and may build momentum in the coming years; 1) South Australia introduced language to acknowledge animal sentience in the Animal Welfare Bill 2025, however this is not yet in operation until Regulations for the Act have been passed which will provide rules for how the Act will be implemented. Once regulations are passed and legislation implemented, South Australia will become the second Australian jurisdiction, joining ACT, to have defined language regarding animal sentience. Victoria is set to be next, with a draft Animal Care and Protection Bill to replace the current Prevention of Cruelty to Animals Act 1986 including sentience provisions. The recognition of sentience and its impact on animals in science is discussed here. 2) The NHMRC announced the review of the Australian Code for the Care and use of Animals for Scientific Purposes (2013) and appointed the Animal Welfare Committee and an Interdepartmental Committee comprised of Commonwealth, State and Territory departments, The Australian Research Council and the CSIRO. 3) The Animals in Science Working Group for the Australian Animal Welfare Strategy Renewal held its inaugural meeting, with AFSA participating in the Working Group as an invited member.
Databases, papers & reports
Incremental progress was made toward the 2023 CSIRO recommendations from the Non-Animal Model Straetgy for Australia with CSIRO releasing the Valuation of Increased Coordination in Australian Biobanking report. Developing a national biobanking and tissue collection network being one of the 10 key recommendations from the 2023 NAMs Strategy report. An article was published by Phenomics Australia titled: Complementarity and integration of animal and in vitro non-animal pre-clinical model systems– an Australian perspective. A report was released commissioned to University of Technology Sydney, Institute for Sustainable Futures, by Stewart Investors titled: Reducing animal testing in the health sector through strategic investment.
In December 2025 NAT-works, The Industry Guide to Non-Animal Technologies database was launched, which platforms NAMs companies globally, allowing users to search for companies that have regulatory approved NAMs test methods, and certifications including ISO and GXP.
Conferences & workshops
The Bellberry & Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT) New Approach Methodologies (NAMs) Introductory Workshop November 2024 report was released summarising the workshop findings on how to navigate the issue of approving ethics for first in human trials based on non-animal model data and another workshop was held as a satellite to AusBioTech in 2025 with workshop report due in Q1 2026. Bellberry is currently working with ASCEPT on a Delphi-informed process to develop draft Human Research Ethics Committee and sponsor guidance on the use of NAM evidence in early-phase clinical trial applications, with a panel discussion planned at WCP to introduce and discuss the draft outputs.
AFSA presented several scientific regulatory talks and webinars at conferences and symposia throughout the year (see AFSA 2025 NAMs Advocacy)
Infrastructure and Industry
The NSW Organoid Innovation Centre (NSWOIC) opening ceremony was held on 26 March 2025. The NSWOIC joins other national infrastructure such as the Australian Organoid Facility in QLD, the Monash Organoid Program, and Phenomics Australia In Vitro hubs positioned nationally.
AFSA 2025 NAMs Advocacy
Key activities for AFSA in 2025 included:
- Release of our Business Case for NAMs summarising major AU (government, industry and university) and global NAMs investment.
- Submissions to the Department of Health, Disability and Ageing – National Health and Medical Research Strategy Consultation, Department of Industry, Science and Resources – Strategic Examination of R&D (phase 2), Department of Industry, Science and Resources – Possible association to Horizon Europe and Department of Education – National Research Infrastructure Roadmap. All AFSA submissions can be found here:
- Presenting at several national and international conferences and symposia:
- International Conference on Research Integrity
- Australia and New Zealand Council for the Care of Animals In Research and Teaching
- Association for Interdisciplinary Meta-research and Open Science
- WA One Welfare: Shared Futures
- WA Animal Welfare Symposium
- ARCs Australia Webinar Regulatory Interest Group
- Sponsoring poster sessions at The Monash Organoid program, and Organoids R Us symposia.
- Hosting several esteemed academic and industry guests for our webinar series and podcast.
2026 Australian NAMs Activities
Several sessions are being held at the World Congress for Pharmacology in 2026 in Melbourne: two NAMs sessions and a workshop titled “Alternative models for pharmacology education to reduce the reliance on rodent models”. A NAMs panel discussion has been held every year at AusBioTech since its inaugural session in 2023 with the launch of the CSIRO NAMs strategy and AFSA hope it will be continued in 2026.
The WA Organoid Innovation Hub at Curtin University is due to open in Q1 2026, funded through the WA Government Future Health and Research Innovation Fund.
Please reach out if you have planned activities that AFSA can promote or sponsor.
AFSA Recommendations and Vision for 2026 and Beyond
- AFSA will continue advocating for federal NAMS funding and will be submitting a federal budget submission to support NAMs validation and development. To express your support for federal funding for NAMs, AFSA Business case can be signed here.
- AFSA will continue to advocate for prohibition of non-human primate use in biomedical science
- The Australia Code (2013) review can have significant impact on the progress and development of NAMs in Australia. AFSA hope to see the NHMRC take leadership in this space and provide funding to support replacement development in alignment with other leading jurisdictions globally.
- AFSA will continue to advocate for opportunities via the Australian Animal Welfare Strategy Renewal process, including funding for alternatives, national reporting of animal use statistics, funding for commissioning a national opinion poll, and increased national oversight and transparency.
AFSA endeavours to provide the most accurate and up to date record of events in Australia related to non-animal model development. If you have any news or events that promote NAMs uptake and or development in Australia that we have missed please reach out – we highly value community contributions.