Xu Miao, Liang Zhenglun, Xu Yinghua, Wang Junzhi
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.
Expert Rev Vaccines. 2015 May;14(5):763-73. doi: 10.1586/14760584.2015.1012503. Epub 2015 Feb 19.
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.
经过几代人的不懈努力，中国已成为世界上少数几个有能力独立满足扩大免疫规划所有要求的国家之一。应用监管科学不断完善疫苗监管体系。通过世界卫生组织的预认证使中国疫苗产品走向全球。中国疫苗产品不仅保障了国内疾病防控，也满足了国际公共卫生需求。本文介绍了中国疫苗发展历程、中国疫苗产业现状及其对传染病防控的贡献。我们还分享了过去几十年国家质量控制和疫苗监管的经验。中国在疫苗研发和质量控制方面的经验可为包括发展中国家在内的全球其他国家和地区带来益处。
