摘要
Abstract
This article systematically explores the transformative impact of new approach methodologies(NAMs),such as organoids,on global drug regulatory science.It analyzes policy developments in regions including the United States and the European Union,and evaluates China's current status and future directions in related research,industrialization,ethical governance,and regulatory frameworks.By reviewing the latest policies and regulations from agencies such as the US Food and Drug Administration(FDA),the National Institutes of Health(NIH),and the European Union,and combining PubMed bibliometric analysis,this study examines the strategic planning of China's Ministry of Science and Technology,National Medical Products Administration(NMPA),and National Natural Science Foundation of China(NSFC).The study finds that limitations of animal experiments are driving the transformation of drug regulatory tools.The United States has elevated organoid technology to a national strategic level.Given its enormous potential in drug development and clinical research,related global research is experiencing explosive growth.Since its first successful establishment in 2009,organoid technology has been recognized as a top annual technology by Science and Nature Methods for its ability to simulate complex organ structures and partial physiological functions,reflecting its widespread recognition in the scientific community.In organoid research,China ranks second globally in the number of published papers.The National Key R&D Program has systematically supported this field,resulting in the emergence of high-quality enterprises,and the Ethical Guidelines for Human Source Organoid Research were released in April 2025.Organoid technology is a key driver of scientific advancement in drug regulation.Currently,China is moving from"following"to"running parallel",and even"leading"in certain areas,but challenges remain in technical standardization,industrial transformation,and the establishment of evaluation standards.In the future,China must continue to strengthen innovation,improve regulatory systems,promote high-quality development of the biopharmaceutical industry,and gradually move towards regenerative medicine goal of organ repair.关键词
类器官/药品监管科学/动物实验替代/新型研究方法学/精准医疗/中国/伦理指引Key words
organoid/pharmaceutical regulatory science/animal testing alternatives/new approach methodologies/precision medicine/China/ethical guidelines分类
医药卫生
