美国FDA在中国设立首个海外机构
2009-05-26 20:36:19   来源：   作者：  评论：0 点击：

BEIJING (Reuters) - U.S. officials opened the first overseas Food and Drug Administration office in Beijing on Wednesday as they gear up for a long battle to ensure the quality of food, drug and feed imports from China.
北京（路透社）-美国首个海外FDA官方机构本周三设在北京，他们为了长期的战略调整以确保从中国出口到美国产品质量与安全。

The eight FDA workers in Beijing, Shanghai and Guangzhou will set up a process for pre-certifying and inspecting imports from China, which has hundreds of thousands of food processors and drug manufacturers.
FDA派驻八名专业人员在北京、上海和广州，FDA会建立一个预先认证程序来和检测从中国出口的物品。

A series of food safety scandals in China, where thousands of babies fell ill after melamine was introduced into milk formula to cheat protein tests, has triggered alarm in the United States, which imports about 15 percent of the food it consumes.
中国一系列食品安全丑闻，用错误的蛋白测试使上千名婴儿吃了含三聚氰胺的牛奶而得病，这是美国对中国的出口食品拉响警钟，中国每年出口15%食品到美国。

Problems with melamine-tainted dairy products from China were so pervasive that the United States issued an import alert, which force importers to certify that the food was problem-free before entering U.S. markets. A similar alert has been in effect on Chinese seafood since last year.
中国三聚氰胺污染的乳制品问题渗透到美国，引起一个进口警钟，使得进口商在食品进入美国前要保证其食品的安全。去年，中国的海产品已拉响了警钟了。

U.S. inspectors have complained in the past of limited access and information when investigating safety disputes with Chinese suppliers and manufacturers, but U.S. Secretary of Health Mike Leavitt said cooperation was improving.
美国检验人员过去常常抱怨调查与中国供应商和生产商争辩质量安全时只有有限的途径和信息，但是美国健康秘书麦克.里维特称，双方的合作正在改善。

Access was "clearly spelled out" in agreements between U.S. and Chinese authorities, Leavitt told reporters.
美国和中国当局之间的协议说得很清楚。

"Heparin, for example, was not one of the drugs under the agreement but those protocols were used and there were U.S. inspectors and Chinese inspectors together visiting the points of production," he said. "Progress is being made."
例如，肝素在协议中不仅是一个药物，而是整个试验设计的问题。美国和中国的检验人员一起访问生产过程的关键点。“这个正在进行中。”

Chinese-made heparin, a blood thinner, was blamed for fatalities and adverse reactions in U.S. and German patients, prompting a recall by Baxter International Inc. early this year.
中国制造的肝素钠（一种血液稀释剂）正被指出在美国和德国病人有致命和副作用，今年早些时候，由Baxter国际有限公司召回。

The FDA offices would try to identify and train laboratories that can certify shipments for faster clearance into the United States, with the goal of ultimately accepting inspections by Chinese quarantine and inspection agency AQSIQ.
FDA正在设法确定能够从中国进口产品进行认证的实验室，并提供必要的培训，加快中国商品在美国的结关速度。

China also plans to station food quality monitors in the United States, the China Daily said on Wednesday. China has on occasion blocked poultry imports from the U.S. as well as meat containing the growth hormone ractopamine, which is banned in China.
中国也计划在美国设立食品监督管理机构，《中国日报》周三称，中国也曾临时对美国的肉制品和家禽产品设禁，因为其中含有在中国被禁的生长激素。

Weak regulation of chemical ingredients used in pharmaceuticals has also allowed manufacturers to sell counterfeit or faulty compounds that are later incorporated into drugs.
稍稍调整药物制剂里面的化学成份已经被生产商允许来售卖伪劣产品，这些都掺杂在药物里面。

The FDA regularly inspects about 100 drug manufacturing facilities in India, which together with China is the main source for generic drugs, Leavitt said. He did not provide a comparable figure for China.
FDA定期检验印度100多家药物生产厂家，里维特称，印度和中国同是普通药的最大来源。他不提供可比较的数据给中国。

It would consider sharing information with inspectors from Japan, Europe, Canada or Australia, Leavitt said, to reduce the burden of monitoring the many manufacturers of generic drugs.
日本、欧洲、加拿大或澳洲的检验人员共享信息，可以降低监督主要生产厂家普通药的负担。