Hot on the heels of global animal-testing phase out announcements in 2025, global momentum is continuing with regulators and public funders beginning to put real structures in place to support animal-free science, from regulatory guidance to validation pathways and major investment in human-based methods.
So, what are these changes? We take you through the recent global progress and what it means for animal-free science.
The US FDA has released draft guidance on the use of new approach methodologies (NAMs) in drug development. Importantly, it recognises that methods do not always need to be fully validated in every context before they can be considered. Instead, the FDA is signalling a more practical, fit-for-purpose approach that could help reduce reliance on animal data and make it easier for sponsors to use human-relevant methods.
In Europe, the European Commission’s Joint Research Centre has published its latest EURL ECVAM status report, highlighting progress in non-animal methods such as organ-on-chip technologies, AI and advanced in vitro tools. Just as importantly, it shows that Europe is building the broader system needed for change, including validation, collaboration, standards and roadmap development for phasing out animal testing.
The UK’S Medical and Healthcare Products Agency has published guidance explaining how medicines developed using non-animal methods may be assessed. It makes clear that scientifically justified animal-free approaches can be acceptable and that, by the end of 2026, companies developing products without animal studies may be able to seek early feedback on their data packages. That is an important step towards reducing regulatory risk for animal-free innovation.
Meanwhile, the US National Institutes of Health has announced more than US$150 million to support human-based research methods that can reduce reliance on animal models. This includes funding for technology development, data-sharing, validation and qualification. It is a strong signal that animal-free science is not only being encouraged in principle but backed with serious public investment.
The European Medicines Agency is also consulting on the use of virtual control groups in certain preclinical studies. While this is not a full replacement of animal testing, it is a meaningful step that could reduce animal use in specific settings and help build confidence in broader non-animal approaches over time.
Taken together, these developments show that the international momentum is real. These developments matter because one of the biggest barriers to replacing animal testing has been uncertainty. Researchers and companies need to know whether non-animal methods will be accepted, how they will be assessed, and what evidence regulators expect. Recent international moves show that this is starting to change
Meanwhile in Australia, the Government is demonstrating no firm commitment to animal-free research. Let’s recap on the last few years.
- In 2022: a NSW parliamentary inquiry report was released with Recommendation 13 stating that: “That the NSW Government commit funding to enable the establishment and operation of a national flagship 3Rs research centre in the state”
- In 2023: CSIRO Futures released a report: “Non-animal Models: A strategy for Maturing Australia’s medical product development capabilities” estimating 1.6 billion in revenue to the Australian Economy by 2040 if acting on the opportunity.
- In 2023: Australian Ethical Investments prepared a statement of support building on the recommendations of the CSIRO report to promote the advancement of non-animal models in Australia. The statement received 27 signatories including from two universities, three research institutes, two health related industry associations, and 12 healthcare companies.
- In 2024: the non-animal technology network (NAT-Net) was founded, from 4.5 million AUD in funding from the NSW government as a result of Recommendation 13 of the Parliamentary Inquiry
- In 2026: The NAT-Net published an article “Building Australia’s non-animal technologies ecosystem: a national cross-sector mapping and strategic insights from the non-animal technologies network (NAT-Net)” which reinforces many of the recommendations of the CSIRO report
Now is the time for the Australian government to take action to fund non-animal models and technologies in Australia, to take advantage of the 1.6 billion estimated increase in revenue to the Australian Economy by 2040 that CSIRO Futures predict if acting on this opportunity now.
ACTION: Support AFSA’s pre-budget submission calling for funding for non-animal models here.