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[资讯分享] 中国产疫苗首次获得国际认证

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发表于 2013-10-10 08:34:17 | 显示全部楼层 |阅读模式
       A Chinese vaccine company has for the first time won international regulatory approval for one of its products, paving the way for its distribution in other parts of the world.  
        一家中国疫苗企业研发的一款产品得到国际监管机构认证,这是中国疫苗产品首次获得此类认证,为该产品在世界其他地区销售铺平了道路。  
        Chengdu Institute of Biological Products, part of China National Biotec, has received “pre-qualification” from the World Health Org-anisation for its vaccine to protect against Japanese encephalitis (JE), a mosquito-borne infection that kills 10,000-15,000 people a year.  
        由中国生物技术股份有限公司(China National Biotec)下属的成都生物制品研究所生产的乙型脑炎减毒活疫苗获得世界卫生组织(WHO)的“预认证”(pre-qualification)。乙型脑炎是一种通过蚊子传播的传染性疾病,每年导致1万至1.5万人死亡。  
        While several other manufacturers make similar JE vaccines, the new single-dose Chinese product is the first to be approved for paediatric use and paves the way for cut-price generic competition.  
        虽然还有数家企业也在生产乙脑疫苗,但中国产的这款单剂型疫苗是首个获批用于儿童患者身上的此类疫苗,这为该产品参与低价非专利药竞争铺平了道路。  
        The regulatory decision reflects the growing influence of pharmaceutical producers from emerging economies, with India already producing many drugs and vaccines with global approval.  
        世卫组织决定颁发上述预认证,反映出来自新兴经济体的制药企业的影响力越来越大。目前,印度已有多种药品和疫苗获得国际认证。  
        China has until now received international regulatory authorisation for “active pharmaceutical ingredients”, the raw materials in medicines, but has not previously had any vaccine or drug approved to global standards.  
        此前中国已有多种“原料药”(即制造药品的原材料)获得国际监管机构认证,但尚无一款疫苗或成药获得国际认证。  
        Many Chinese manufacturers have until now been dissuaded from seeking pre-qualification because of the costs and the fact that they could still win domestic or regional approvals and focus on these sales more easily and cheaply.  
        到目前为止,许多中国制药企业都无意寻求通过世卫组织的预认证,一方面是因为成本较高,另一方面是因为它们可以比较轻松地且以较低成本获得国内或地区认证,专注于这些市场的销售。  
        The Chengu Institute’s JE product now has the prospect of being purchased by international donors via the Global Alliance on Vaccines and Immunisation (Gavi) for distribution in areas of Asia where JE is endemic.  
        成都生物制品研究所生产的乙脑疫苗在取得世卫组织的预认证后,有望通过全球疫苗免疫联盟(Gavi)获得国际捐助者的采购。这些捐助者将在乙脑高发的亚洲地区分发疫苗。  
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