Regulatory science in drug evaluation is a process of making scientific decisions based on evidence and patients'medication needs,crucial for ensuring drug accessibility and timely translation of innovation research and development results.This paper summarizes the development history and progress of regulatory science in China's Drug Evaluation,analyzes existing problems,and draws insights from the experience of regulatory science in Europe and the United States to propose further considerations to optimize the top-level design and operational mode of regulatory science,aiming to promote China's drug evaluation technical standards system.
关键词
药品/监管科学/发展历程/工作进展/药品审评技术标准体系
Key words
drug/regulatory science/development history/work progress/drug evaluation technical standards system
维普
万方数据