中国食品药品监管Issue(6)：28-35,8.DOI:10.3969/j.issn.1673-5390.2026.06.003
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
Regulatory Trends in the Reduction or Replacement of Animal Testing for Pharmaceuticals in China,and the Plans and Progress of Related Research Programs
摘要
Abstract
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.关键词
药物/动物试验减少或替代/监管科学/监管动态/新方法Key words
pharmaceuticals/reduction or replacement of animal testing/regulatory science/regulatory trends/new approach methodologies(NAMs)分类
医药卫生引用本文复制引用
闫莉萍,周宇,张旻,孙涛,杨志敏..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[J].中国食品药品监管,2026,(6):28-35,8.基金项目
药品监管科学全国重点实验室课题(2026SKLDRS03100) （2026SKLDRS03100）
