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FDA Unveils Landmark Roadmap to Replace Animal Testing in Preclinical Safety Studies

Animal-Free Science Advocacy

On 10 April 2025, the U.S. Food and Drug Administration (FDA) announced a historic roadmap to phase out routine animal testing in preclinical safety and toxicity studies, replacing it with new approach methodologies (NAMs) grounded in human biology. Over the next three to five years, the FDA’s goal is for animal studies to become the exception rather than the norm in drug development.

“By leveraging AI-based computational modelling, human organ-model lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices,” said FDA Commissioner Martin Makary. “It is a win-win for public health and ethics.”

The roadmap identifies monoclonal antibodies (mAb), as a promising area for reducing animals as the first step of the roadmap. Monoclonal antibodies (mAbs), also known as therapeutic antibodies, are a type of drug that uses antibodies to target specific immune functions for specific diseases or conditions.  Animals often mount immune responses to human mAbs. As such, currently mAb repeat-dose toxicity studies are conducted in animals, including non-human primates. However, animal immunogenicity is not predictive of human immunogenicity and results in costly and lengthy animal trials with scientific limitations and ethical challenges.

The roadmap builds on the FDA Modernization Act 2.0, which empowered the agency to accept NAMs in lieu of animal studies. The forthcoming FDA Modernization Act 3.0—expected to be enacted in the coming months—will establish a formal qualification process for nonclinical testing methods, ensuring guideline alignment and legislative intent are fully realised.

On the same day of the roadmap announcement, the U.S. Environmental Protection Agency (EPA) announced plans to reinstate its mammalian testing phase-out for chemical and pesticide safety assessments, prioritising non-animal alternatives. Transition frameworks are already underway in the Netherlands, the UK, Norway, Sweden and the EU.

Call to Action for Australia

Despite global momentum, Australia has yet to commit to similar measures. A 2023 CSIRO Non-Animal Models report set out a strategy to mature Australia’s medical-product development capabilities, recommending alignment of the Therapeutic Goods Administration (TGA) processes and industry guidance with the new FDA procedures. However, no government commitment has followed, leaving drug sponsors uncertain whether NAM data will be accepted in place of animal studies.

Animal-Free Science Advocacy (AFSA) is calling on the Albanese Government to:

1. Endorse the CSIRO non-animals report and commit to a national roadmap for NAMs adoption.
2. Allocate resources to update TGA processes and secure Australia’s participation in key international discussions.
3. Ensure regulatory alignment with leading global standards to support faster, safer and more cost-effective drug development.

“As the world’s leading regulator and other nations take decisive action to promote ethical, cost-effective and human-relevant drug development, it’s time Australia follows the FDA lead,” said AFSA spokesperson Rachel Smith. “The new FDA roadmap includes incentives for modern, animal-free methods—and it’s an important recognition of the value of NAMs for human health and animal welfare.”

“The FDA’s bold move to make animal testing the exception marks a turning point for global drug development. As a biotechnology company pioneering AI-integrated, human-relevant 3D tissue culture systems, Gelomics strongly supports AFSA’s call for the Australian Government to align with international best practice. Australia must act now to modernise its regulatory framework and establish a national roadmap for non-animal methodologies (NAMs). Doing so will not only accelerate access to safer, more effective therapies, but also ensure our local industry remains globally competitive.”

— Dr Christoph Meinert, CEO and Co-Founder, Gelomics

In related news; the National Institutes of Health has announced a major commitment to transitioning away from animal research in favour of innovative, human-based science. With no funding incentives for NAMs in Australia; Australia looks set to lag behind.

 

Key Facts:

·       FDA aims to make animal studies the exception rather than the norm within 3–5 years by embracing new approach methodologies (NAMs) based on human biology.

·       Roadmap leverages AI-based computational modelling, human organ-model lab testing and real-world human data.

·       Monoclonal antibodies (mAbs) identified as first priority; animal immunogenicity not predictive of human response.

·       AFSA urges the Australian Government to endorse CSIRO non-animal report recommendations and align TGA guidelines with the FDA.

About us:

AFSA is a non-profit organisation advocating for the replacement of animals in research and teaching. 

Gelomics is revolutionizing drug development by enabling the growth of human tissue models in vitro. This provides an ethical, cost-effective, and predictive alternative to animal testing.