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认证 中国生产的疫苗首次通过世界卫生组织预认证 发布时间: 2013-10-09 23:25 点击:

认证 中国生产的疫苗首次通过世界卫生组织预认证
Chinese production of the vaccine is the first certified by who pre authentication
据国家食品药品监督管理总局网站消息,10月9日,世界卫生组织(WHO)通报国家食品药品监督管理总局,中国生产的乙型脑炎减毒活疫苗通过了WHO的疫苗预认证,成为中国通过WHO预认证的首个疫苗产品。
According to the State Food and Drug Administration website news, October 9th, who (WHO) informed the State Food and drug administration, China's production of live attenuated Japanese encephalitis vaccine vaccine by the pre WHO certification, to become China's first through the WHO pre authentication vaccine products.
  2013年10月9日,世界卫生组织(WHO)通报国家食品药品监督管理总局,中国生物技术股份有限公司下属的成都生物制品研究所有限责任公司生产的乙型脑炎减毒活疫苗通过了WHO的疫苗预认证,成为中国通过WHO预认证的首个疫苗产品。这标志着在经历了不懈的努力后,中国疫苗产品的监管、研制和生产获得了国际的广泛认可,产品得以进入国际市场。
In October 9, 2013, who (WHO) informed the State Food and Drug Administration of China, Chengdu Biological Products of biotechnology Limited by Share Ltd under the limited liability company production of live attenuated Japanese encephalitis vaccine vaccine by the pre WHO certification, become the first vaccine products to China through the WHO pre authentication. This marks after unremitting efforts, China vaccine products supervision, development and production of the widespread international recognition, products to enter the international market.
  国产乙型脑炎疫苗通过WHO的疫苗预认证后,联合国采购机构即可将此产品列入采购目录。更重要的是,因中国产疫苗产品的质量、产能和价格优势,将为发展中国家儿童免于乙脑危害提供有力支撑。对此,世卫组织总干事陈冯富珍博士表示“中国疫苗生产潜力巨大,我们希望能够看到越来越多的中国疫苗产品通过世界卫生组织的预认证,全世界都会因此而受益”。
Domestic Japanese encephalitis vaccine vaccine pre authentication through WHO, you can purchase agencies of the United Nations the products listed in the catalogue. What is more important, because the Chinese vaccine product quality, production capacity and price advantage, will provide strong support for developing children from harm of je. In this regard, the WHO director general Dr. Chen Fengfuzhen said "China vaccine production potential, we hope to be able to see more and more Chinese vaccine products by pre certification who, the world will benefit from this".
  2011年3月WHO宣布中国国家药品监管机构通过了世界卫生组织疫苗监管体系的评估,从此,中国的疫苗生产企业具备了申请世界卫生组织疫苗预认证的资格,打开了中国疫苗产品进入国际市场的大门。近年来,随着食品药品监管部门通过推行新修订药品GMP(2010版)等多项措施,不断提高生产标准和监管水平,我国药品生产企业整体水平迅速提高,为中国疫苗产品获得国际认可创造了条件。
In 2011 March, WHO announced that China national drug regulatory mechanism through the assessment, who vaccine supervision system from China, vaccine production enterprises have applied for who vaccine pre certification qualifications, opened the Chinese vaccine products to enter the international market door. In recent years, with the food and drug administration through the implementation of the new revised Drug GMP (2010 Edition) and a number of measures, and continuously improve the production standards and the supervision level, the overall level of Chinese medicine production enterprises increased rapidly, to create the conditions for the Chinese vaccine products gained international recognition.
  据了解,乙型脑炎是一种由蚊子叮咬传播的疾病,会导致大脑炎症,其地域性季节性的流行属于世界性重大公共卫生问题。由于目前没有针对乙脑的专门治疗手段,注射疫苗是一项有效预防措施。
It is understood, Japanese encephalitis is a disease transmitted by mosquitoes, can cause inflammation of the brain, the popular regional seasonal belongs to a major public health problem worldwide. Because there is no specific treatment for JE, vaccination is an effective preventive measure.
认证 中国生产的疫苗首次通过世界卫生组织预认证
Chinese production of the vaccine is the first certified by who pre authentication