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(双语新 ) 中国第 大狂犬病疫苗制造商停止生产

青岛希 尔翻译公 (www..cn)整理 布2018-07-24

希尼尔 译公司(www..cn)2018年7月24日了解 :China Food and Drug Administration (CFDA) has issued an announcement asking Changchun Changsheng Life Sciences, China’s second-biggest rabies vaccine maker, to terminate the production of its Vero-cell rabies vaccines.

中国食 药品监督管理局( CFDA )发布公 ,要求中国第二大狂犬病疫苗制造商长春长生生命科学公司停止生产Vero细胞狂 病疫苗。

The announcement came after authorities carried out a snap inspection and found the company forging production data and violating the country’s drug production quality management protocols.

此前, 局进行了突击检查,发现该公司伪造生产数据,违反了国家药品生产质量管理协议。

The CFDA has asked the provincial food and drug administration of Jilin, where the company is based, to revoke Changchun Changsheng’s Good Manufacturing Practice (GMP) certificate, an international recognized license for drug production.

国家食 药品监督管理局已要求公司所在地吉林省食品药品监督管理局吊销长春长生药品生产国际认可许可证(GMP)。

CFDA stated that the batch of rabies vaccines involved in the inspection had not been put on the market and had been “effectively controlled.” Inspectors from both state and provincial food and drug administrations have been stationing at the company for further investigation.

CFDA表示,与检查的那批狂犬病疫苗尚未投放市场,并已得到“有效控制”。国家食品药品监督管理局和省级食品药品管理局的检查员一直在这家公司进行进一步 调查。

Changchun Changsheng’s parent company, Shenzhen-listed Changsheng Biotechnology, has made a public apology and voluntarily recalled all their rabies vaccines available on the market.

长春长 的母公司、在深圳上市的长生生物技术有限公司(Changsheng Biotechnology)已公开 歉,并主动召回市面上所有的狂犬病疫苗。

The company stated the recall would cost over 200 million yuan (approximately 30 million US dollars) of the company’s business income. Zhao Chunzhi, secretary to the president at Changsheng Biotechnology, told China Securities Journal that sales revenue from rabies vaccine products counted for half of Changchun Changsheng’s gross revenue.

该公司 示,此次召回将花费公司业务收入的2亿元人 币(约3000万美元)。常胜 物技术公司总裁秘书赵春志告诉《中国证券报》,狂犬病疫苗产品的销售收入占长春常胜总收入的一半。

This is not the first time Changsheng Biotechnology and its subsidiaries have been involved in drug safety scandals. On July 18, Jilin provincial food and drug administration announced the investigation result into Changchun Changsheng’s DTaP vaccine.

这并不 长生生物科技公司及其附属公司第一次卷入药品安全丑闻。7月18日,吉 省食品药品监督管理局公布了长春长胜DTaP疫苗的 查结果。

Last year, a batch of the vaccines immunizing children against whooping cough, diphtheria and tetanus were found failing to conform to standards for biological potency. According to the report, 252,600 vaccines in the batch had been sold to disease control and prevention centers throughout east China’s Shandong Province.

去年, 批免疫儿童对抗百日咳、白喉和破伤风的疫苗被发现不符合生物效力标准。根据该报告,这批疫苗中有252,600种已经 给了中国东部山东省的疾病控制和预防中心。

来源:中国国 电视台

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