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Abstract
Through the continuous efforts of several generations, China has become one of the few countries in the world that is capable of independently addressing all the requirements by the Expanded Program on Immunization. Regulatory science is applied to continuously improve the vaccine regulatory system. Passing the prequalification by WHO has allowed Chinese vaccine products to go global. Chinese vaccine products not only secure disease prevention and control domestically but also serve the needs for international public health. This article describes the history of Chinese vaccine development, the current situation of Chinese vaccine industry and its contribution to the prevention and control of infectious diseases. We also share our experience of national quality control and vaccine regulation during the past decades. China’s experience in vaccine development and quality control can benefit other countries and regions worldwide, including the developing countries.
Financial & competing interests disclosure
This work was supported by 863 Project (No. 2012AA02A402) and National Major Scientific and Technological Special Project (No. 2013ZX09304101) from the Ministry of Science and Technology, China. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
China has a total of 41 vaccine-manufacturing companies that produce 55 varieties of vaccines against 27 infectious diseases. These vaccines also cover the marketed vaccine products in developed countries. China has become one of the few countries in the world that is able to independently address all the requirements of Expanded Program on Immunization (EPI).
China started to implement EPI in 1978. The EPI vaccines have now been extended from those covering six diseases to the current 14 varieties against 15 diseases. The incidences of major infectious diseases have been reduced to historically low levels, including measles, whooping cough, diphtheria, tetanus, epidemic meningitis, Japanese encephalitis, hepatitis B and hepatitis A. China has maintained its poliomyelitis-free status since 2000.
In 2013, the live-attenuated Japanese encephalitis vaccine became the first Chinese vaccine product that was prequalified by the WHO. This success marked the first step of Chinese vaccines going global.
The Chinese National Regulatory Authorization (NRA) system continues to improve. The NRA passed the assessment in 2010 and the reassessment in 2014 by the WHO. China is one of the 36 countries with complete NRA regulatory functions in the world.
National Institutes of Food and Drug control (NIFDC) became the seventh WHO Collaborating Center for standardization and evaluation of biologics in 2013, which plays a strong role as a collaborating center in different regions. Furthermore, NIFDC, as National Clinical Laboratory, is devoted to apply scientific regulation to the research and development of new vaccines through close cooperation with vaccine manufacturers and other related institutes to accelerate new vaccine development.
Vaccine management in China has been improved from empirical management with simple sample inspection to comprehensive whole-process scientific management. The concept of ‘regulatory science’ has gradually emerged and evolved along with developing a variety of new vaccines and solving a range of associated regulatory issues.