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我国药品审评中药品监管科学研究工作进展与思考

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药品监管科学是基于科学证据和患者用药需求做出科学决策的过程,其发展进程关乎患者用药可及性和药物创新研发成果转化及时性.本文对我国药品审评中药品监管科学发展历程和工作进展进行概述和分析,同时参考欧美药品监管科学发展经验,提出下一步工作思考,以期优化药品监管科学顶层设计和工作模式,推动我国药品审评技术标准体系的完善.
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

余明丽、温宝书、白玉

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国家药品监督管理局药品审评中心

药品 监管科学 发展历程 工作进展 药品审评技术标准体系

"重大新药创制"国家科技重大专项(2017)

2017ZX0901001-001-002

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(4)
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