中国药物动物试验减少或替代监管动态及相关课题研究计划和进展OA

In recent years,the ethical concerns and technical limitations associated with animal testing have become increasingly prominent.The reduction or replacement of animal testing in drug development has emerged as a key focus for regulatory authorities worldwide.This article introduces the objectives,research content,progress,timeline,and overall regulatory framework of the project Exploration of Strategies for Reducing or Replacing Animal Testing in Nonclinical Drug Research,conducted under the National Key Laboratory of Regulatory Science for Pharmaceuticals.Particular attention is given to the application of new approach methodologies(NAMs)as alternatives to,or reductions in,animal testing.The paper aims to enhance public understanding of China's regulatory developments in this area and to encourage coordinated efforts between regulators and industry stakeholders to advance the systematic implementation of animal testing reduction or replacement strategies.