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Review on Drug Regulatory Science Promoting COVID-19 vaccine Development in China

Engineering 2022年第3期8卷 127-132页

作者： Zhiming Huang Zhihao Fu Junzhi Wang National Medical Products Administration Beijing 100053China National Institutes for Food and Drug Control Beijing 102629China

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 *** the pandemics induced by infectious diseases,such as H1N1 flu,severe acute respiratory syndrome(SARS),and Middle East respiratory syndrome(MERS),regulatory science strongly supported the development of drugs and vaccines to respond to the *** 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 vaccine industry,research and development(R&D)of COVID-19 vaccines in China,and the general state of regulatory science and supervision for vaccines in ***,this review highlights how regulatory science has promoted the R&D of Chinese COVID-19 vaccines,with analyses from the aspects of nationallevel planning,relevant laws and regulations,technical guidelines,quality control platforms,and postmarketing ***,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.

关键词： Regulatory science COVID-19 vaccine vaccine industry

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