Progress and Reflections on Regulatory Science and Research in China's Drug Evaluation
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.
drugregulatory sciencedevelopment historywork progressdrug evaluation technical standards system