中国食品药品监管Issue(1)：6-17,12.DOI:10.3969/j.issn.1673-5390.2025.01.001
监管科学驱动我国疫苗新质生产力应对全球公共卫生事件
Regulatory Science Drives the New Quality Productivity of Chinese Vaccine to Address Global Public Health Challenges
李小静 1李敏 1鲁爽 1王庆利 2何伍 1王涛1
作者信息
- 1. 国家药品监督管理局药品审评中心
- 2. 中国食品药品检定研究院
- 折叠
摘要
Abstract
To adapt to the development of new technologies,products,industries,and models—especially in response to the demand for addressing major public health emergencies—the National Medical Product Administration(NMPA)has actively promoted regulatory science research for public health products.It has continuously refined review and approval policies,strategically and systematically planned vaccine research and development(R&D),and since 2003,established an emergency review and approval mechanism for vaccines against emerging infectious diseases through a series of policies and regulations.These efforts have continuously advanced vaccine innovation and internationalization,improved the quality and efficiency of reviews and approvals,accelerated the development and market entry of innovative vaccines,and propelled the rapid growth of China's vaccine industry's new quality productivity.This progress has facilitated alignment with international standards and achieved significant outcomes in multiple global public health emergencies.This paper systematically reviews the history and trends of vaccine R&D in China,summarizes the progress of reforms in review and approval processes,and highlights the unique aspects of vaccine regulation in responding to major public health needs.It underscores how scientific regulatory practices can accelerate vaccine development.By consolidating historical experiences and analyzing the current R&D ecosystem,this paper aims to provide insights for leveraging regulatory science to drive industry development,further supporting vaccine innovation,improving review and approval quality and efficiency,and comprehensively promoting the high-quality development of the vaccine industry.关键词
药品监管/疫苗/审评审批/创新/高质量发展Key words
drug regulation/vaccines/review and approval/innovation/high-quality development分类
医药卫生引用本文复制引用
李小静,李敏,鲁爽,王庆利,何伍,王涛..监管科学驱动我国疫苗新质生产力应对全球公共卫生事件[J].中国食品药品监管,2025,(1):6-17,12.
