Thursday 19/March/2026 – 03:23 PM
The US Food and Drug Administration has announced the release of new draft guidance aimed at reducing reliance on animal experiments in the early stages of drug development, while encouraging the use of modern techniques based on computer simulations and models that mimic the functions of human organs, according to Reuters.
This step seeks to support pharmaceutical companies in adopting what is known as new approach methodologies, which are non-animal testing tools that are used when submitting non-clinical safety data within drug approval applications.
An American trend to reduce animal experiments in drug development
The new methods rely on a range of advanced technologies, including in vitro cell tests and 3D models such as organoids, small structures that grow human cells and function like real organs. The administration asserts that these methods may be better able to simulate the human response compared to traditional animal experiments.
In this context, American officials indicated that the new directive reflects an increasing commitment to replacing animal experiments with more accurate and human-related scientific alternatives, especially in light of the great development in modern research tools.
Despite the widespread use of animals in drug testing, many treatments that work at this stage are unable to pass safety and effectiveness tests when tried on humans. This highlights the limitations of these models in accurately predicting clinical outcomes.
The Food and Drug Administration had previously issued similar guidance to reduce the use of non-human primates, especially in testing certain biological drugs such as antibodies.
It is expected that these trends will contribute to accelerating the drug development process and reducing its cost, as estimates indicate that the use of artificial intelligence tools and modern technologies may reduce the time and cost of research and development by a significant percentage in the coming years.
In the same context, the National Institutes of Health announced an investment of $150 million in research based on human models, in a step that supports reducing reliance on animals and enhancing the accuracy of scientific results.
These moves reflect a growing shift in the pharmaceutical sector towards adopting more efficient and ethical methods, which contributes to improving the quality of treatments and reducing their costs for patients.
