Policy moves from the UK, the U.S. FDA and the NIH, alongside major investments in China, are accelerating a shift away from traditional animal testing toward new-approach methodologies (NAMs) such as organs‑on‑chips, organoids and advanced computational models. Reports show rapid growth in human-cell based systems and calls from regulators to make animal studies the exception for certain safety assessments. The transition presents both scientific and regulatory opportunities: NAMs can better model human biology in some contexts and could streamline preclinical pipelines, but widespread adoption will require standardization, validation studies, and new regulatory frameworks to replace entrenched animal‑based paradigms.