典型文献
Review on Drug Regulatory Science Promoting COVID-19 Vaccine Development in China
文献摘要：
Regulatory science is a discipline that uses comprehensive methods of natural science,social science,and humanities to provide support for administrative decision-making through the development of new tools,standards,and approaches to assess the safety,efficacy,quality,and performance of regulated products.During the pandemics induced by infectious diseases,such as H1N1 flu,severe acute respira-tory syndrome(SARS),and Middle East respiratory syndrome(MERS),regulatory science strongly sup-ported the development of drugs and vaccines to respond to the viruses.In particular,with the support of research on drug regulatory science,vaccines have played a major role in the prevention and control of coronavirus disease 2019(COVID-19).This review summarizes the overall state of the vac-cine industry,research and development(R&D)of COVID-19 vaccines in China,and the general state of regulatory science and supervision for vaccines in China.Further,this review highlights how regulatory science has promoted the R&D of Chinese COVID-19 vaccines,with analyses from the aspects of national-level planning,relevant laws and regulations,technical guidelines,quality control platforms,and post-marketing supervision.Ultimately,this review provides a reference for the formulation of a vaccine development strategy in response to the current pandemic and the field of vaccine development in the post-pandemic era,as well as guidance on how to better respond to emerging and recurring infectious diseases that may occur in the future.
文献关键词：
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作者姓名：
Zhiming Huang;Zhihao Fu;Junzhi Wang
作者机构：
National Medical Products Administration,Beijing 100053,China;National Institutes for Food and Drug Control,Beijing 102629,China
文献出处：
引用格式：
[1]Zhiming Huang;Zhihao Fu;Junzhi Wang-.Review on Drug Regulatory Science Promoting COVID-19 Vaccine Development in China)[J].工程（英文）,2022(03):127-132
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AB值：
0.566165
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