Korea Takes Lead in Global Standards for Animal-Free Testing

The push to replace traditional animal testing stems from the recognized biological differences between animals and humans, which can limit the predictive accuracy of such tests for human effects. Regulatory bodies, including the U.S. Food and Drug Administration and the European Union, are establishing frameworks and roadmaps to integrate New Approach Methodologies (NAMs). These methods leverage technologies like artificial intelligence, omics, and organ-on-a-chip devices to assess safety with greater human relevance.

Korea's upcoming role as host for the OECD ESCA meeting, which has previously taken place in France, suggests its evolving position in regulatory science. The country has already seen domestically developed test methods, such as an animal-free phototoxicity test using a Korean-made human skin model, reflected in OECD international standards. This indicates a progression from adopting international norms to actively influencing them.

At the meeting, the Ministry of Food and Drug Safety intends to present a liver organoid-based toxicity test method, proposed as the OECD's first toxicity test using organoids. This effort aims to gather international expert views on integrating organoid technology into global safety assessment standards. Following the ESCA meeting, an International Symposium on Human-Centered NAMs Regulatory Science will further discuss the regulatory adoption of these technologies and their competitiveness in global standardization.