For more than a century, animal testing has underpinned safety assessments of drugs and chemicals. Examining how animals respond has long been a regulatory principle in developing new drugs and verifying the hazards of chemical substances. Now, however, a sweeping shift is unfolding in global regulatory practice.
The reason is clear. Biological differences between animals and humans limit how well such tests predict effects on people. The U.S. Food and Drug Administration established an institutional basis for using methods other than animal testing through the Modernization Act 2.0 in 2022. The European Union is likewise pursuing a roadmap to phase down animal testing in chemical safety assessments.
At the center of this shift are new approach methodologies (NAMs), which replace animal testing. This is next-generation regulatory science that draws on advanced technologies — artificial intelligence, omics, organ-on-a-chip devices and organoids — to predict effects on the human body more accurately and assess safety.
Amid this change in paradigm, the Organisation for Economic Co-operation and Development will hold a meeting of its Advisory Group on Emerging Science in Chemical Assessment (ESCA) in Seoul from the 14th to the 15th of this month. ESCA is a core OECD advisory body on regulatory science that shares trends in emerging science and technology and discusses international standards for applying new technologies to safety assessment.
Holding in Korea a meeting that has previously taken place in France, where the OECD is based, shows that the country has moved beyond learning from the international community to become a player helping steer global discussions. It is also the fruit of the Ministry of Food and Drug Safety's work in having a number of domestically developed test methods reflected in OECD international standards, including an animal-free phototoxicity test using a Korean-made human skin model.
At the meeting, the ministry plans to present a liver organoid-based toxicity test method — proposed as the OECD's first toxicity test using organoids — and gather views from international experts. Following the ESCA meeting, an International Symposium on Human-Centered NAMs Regulatory Science will be held on the 16th, bringing together global experts, industry and academia. The event will share the status of NAMs efforts and explore regulatory adoption of domestically developed NAMs technologies and their competitiveness in global standardization.
Securing global leadership in NAMs requires competitiveness in regulatory science and an integrated cooperation framework linking industry, academia, research institutes and government. A virtuous cycle must function in which research institutions develop innovative core technologies, the government builds assessment systems, and industry actively applies them to drug development.
To that end, the ministry will establish a NAMs Initiative in 2027 as a consultative body spanning industry, academia, research institutes and government, supporting development and validation and strengthening cooperation so that strong domestic technologies can grow into global technologies that lead pharmaceutical development. We hope the Seoul ESCA meeting becomes an important turning point as Korea's NAMs regulatory science advances toward becoming a world standard.
