Signal FDA Modernization Act 3.0 and national strategies accelerate acceptance of non-animal test methods

Summary

Regulatory acceptance of new approach methodologies that replace or complement animal testing is advancing quickly. KISTEP cites the US FDA Modernization Act 3.0 and an FDA roadmap as drivers of this shift. It also observes moves in the US, the EU and East Asia to designate organoid and organ chip infrastructure as national strategic technology. As social demands to reduce animal testing align with regulatory direction, countries and companies that invest early in such infrastructure are expected to capture the benefits of global regulatory change. Countries that build standardisation and data-sharing systems first are expected to gain strong influence over future global rules and standards.