USA establishes new framework for animal-free research

: Press release; Published: 23 March 2026

Moving away from animal experiments as the standard in drug development

The United States is accelerating the transition to modern, human-based research methods in medicine. With extensive investments and new regulatory guidelines, the country is increasingly focusing on approaches that do not rely on animal experiments but instead are directly oriented toward human biology. The nationwide association Doctors Against Animal Experiments (DAAE) sees this as an important step toward efficient and reliable research and is calling on Germany to finally follow suit.

The U.S. health authority National Institutes of Health (NIH) is investing more than 150 million US dollars in so-called New Approach Methodologies (NAMs). These include organoids, organ-on-chip systems, and computer-based models. Unlike so-called animal models, these methods can realistically replicate human disease processes, thereby increasing the predictive power of pharmaceutical research and improving the successful translation of research findings into effective therapies (1).

At the same time, the U.S. drug regulatory agency Food and Drug Administration (FDA) has presented a draft for a new guideline that defines a structured framework for validating these methods. Validation refers to the scientific proof that a method works reliably and is suitable for a specific purpose. This has so far been a central obstacle to the broad regulatory acceptance of NAMs. The FDA now outlines clear criteria, including the context of use, biological relevance to humans, technical reliability, and suitability for regulatory decision-making. In doing so, the agency lays the foundation for simplifying the use of NAMs in approval procedures (2).

In an accompanying press release, the FDA also makes it clear that animal experiments should no longer be regarded as the standard in drug development in the long term. Instead, human-relevant methods are to be increasingly used to assess the safety and efficacy of new substances. This is based on growing scientific evidence that animal “models” do not reliably predict human biological responses. The FDA emphasizes that there are already validated NAMs today that enable better predictions than traditional animal models, whose predictive value for humans has not been validated (3).

“The current developments in the United States show a fundamental shift in biomedical research. Human-based methods are evolving from complementary approaches into central pillars of drug development,” says Dr. Johanna Walter, scientific advisor at DAAE. “It is particularly significant that multiple authorities are actively shaping this change - hand in hand - and creating clear framework conditions for the development and application of these methods.”

The combination of targeted research funding, regulatory support, and strategic coordination across agencies signals a systemic transformation. Programs such as the NIH funding initiative Complement-ARIE ensure that new methods are not only developed but also validated, standardized, and integrated into regulatory practice (4). This creates a coherent approach that links research, evaluation, and application.

From the perspective of DAAE, these measures are groundbreaking: “The new developments in the United States demonstrate that the transition to modern, human-relevant research is not only technologically feasible but also politically and regulatorily achievable,” Walter adds.

Similar developments are also emerging internationally: for example, the European Union is working on a roadmap for the gradual phase-out of animal testing in the safety assessment of chemicals.

In light of these developments, DAAE sees an urgent need for action in Germany. In order to remain internationally competitive, a binding strategy to phase out animal experiments, targeted investments in human-based methods, and their consistent integration into regulatory procedures are necessary. Without appropriate political action, Germany risks falling behind international developments.

USA establishes new framework for animal-free research

Moving away from animal experiments as the standard in drug development

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