title: Chinese vaccine products go global: vaccine development and quality control.
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.
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, No.2, Tiantan Xili, Dongcheng District, Beijing 100050, People's Republic of China.
authors.forename: Miao
authors.initials: M
authors.lastname: Xu
authors.forename: Zhenglun
authors.initials: Z
authors.lastname: Liang
authors.forename: Yinghua
authors.initials: Y
authors.lastname: Xu
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
mesh_terms: D002681:China; D003906:Developing Countries; D017277:Drug Approval / Q000379:methods*; D055808:Drug Discovery / Q000266:history / Q000639:trends*; D004345:Drug Industry / Q000266:history*; D014943:Global Health; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*; D014612:Vaccines / Q000266:history / Q000302:isolation & purification* / Q000592:standards* / Q000600:supply & distribution
chemical_list: D014612:Vaccines
keywords: China; WHO prequalification; infectious diseases; quality control; regulatory science; vaccine