The development of China’s vaccine industry in the past decade: the perspective from drug regulatory science

Abstract

Analysis of the batch issued data of Chinese vaccines from 2011 to 2020 showed that the average annual dose of vaccines in China was 769.66 million doses, and the overall production was stable. Fourteen new vaccines were added, six of which were developed in China. The batch issued dose of national immunization program (NIP) vaccine was stable with slightly decreased, while the non-NIP vaccine showed an increasing trend. The development trend of combined vaccine increased significantly. Regulatory science in China’s development, promoted the China’s vaccine regulation the perfection of legal system, and the steady improvement of vaccine quality and standards, and the gradual maturity of the construction of lot release system. With the goal of being safe, effective, reasonable, and accessible, China’s vaccines encourage the research and development of new technologies and emergency vaccines to constantly improve the level of public health.