中國產疫苗首次獲得國際認證
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.
一家中國疫苗企業研發的一款產品得到國際監管機構認證，這是中國疫苗產品首次獲得此類認證，爲該產品在世界其他地區銷售鋪平了道路。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.
由中國生物技術股份有限公司(China National Biotec)下屬的成都生物製品研究所生產的乙型腦炎減毒活疫苗獲得世界衛生組織(WHO)的“預認證”(pre-qualification)。乙型腦炎是一種通過蚊子傳播的傳染性疾病，每年導致1萬至1.5萬人死亡。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.
雖然還有數家企業也在生產乙腦疫苗，但中國產的這款單劑型疫苗是首個獲批用於兒童患者身上的此類疫苗，這爲該產品參與低價非專利藥競爭鋪平了道路。
The regulatory decision reflects the growing influence of pharmaceutical producers from emerging economies, with India already producing many drugs and vaccines with global approval.
世衛組織決定頒發上述預認證，反映出來自新興經濟體的製藥企業的影響力越來越大。目前，印度已有多種藥品和疫苗獲得國際認證。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.
此前中國已有多種“原料藥”（即製造藥品的原材料）獲得國際監管機構認證，但尚無一款疫苗或成藥獲得國際認證。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.
到目前爲止，許多中國製藥企業都無意尋求通過世衛組織的預認證，一方面是因爲成本較高，另一方面是因爲它們可以比較輕鬆地且以較低成本獲得國內或地區認證，專注於這些市場的銷售。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.
成都生物製品研究所生產的乙腦疫苗在取得世衛組織的預認證後，有望通過全球疫苗免疫聯盟(Gavi)獲得國際捐助者的採購。這些捐助者將在乙腦高發的亞洲地區分發疫苗。
