我国疫苗监管发展概况OA
Overview of Vaccine Regulatory Development in China
科学、有效、权威的监管,在保证疫苗安全性、有效性和质量可控性上发挥着重要作用.本文阐述了新中国成立以来我国疫苗监管的发展历程,同时对我国疫苗监管现行的主要制度进行了系统梳理,探究各制度对疫苗监管的重要作用;阐述了我国在世界卫生组织(WHO)疫苗国家监管体系(NRA)评估中的表现;总结了目前我国疫苗产业发展现状,并提出发展建议.
Scientific,effective and authoritative regulation plays an important role in ensuring the safety,effectiveness and quality control of vaccines.This paper elucidates the development history of China's vaccine regulation since the founding of the People's Republic of China.Additionally,it systematically reviews the current main systems of China's vaccine regulation to explore the pivotal role of each system in vaccine regulation.The paper also discusses China's performance in the World Health Organization's(WHO)assessment of the National Regulatory Authority(NRA)for vaccines.On this basis,we summarize the current development status of China's vaccine industry and put forward development suggestions.
张燕玲;牟鑫爽;茅宁莹;张伟
中国健康传媒集团健康中国研究院中国药科大学国际医药商学院中国药科大学国际医药商学院中国药品监督管理研究会
医药卫生
疫苗监管监管体系疫苗管理法疫苗法规
vaccine regulationregulatory systemvaccine administration lawvaccine regulations
《中国食品药品监管》 2023 (11)
28-35,8
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