【双语新闻】国家药监局:已责令长春长生停产 对企业立案调查

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.

中国食品药品监督管理局(CFDA)发布公告,要求中国第二大狂犬病疫苗制造商长春长生生命科学有限公司终止其冻干人用狂犬病疫苗的生产。

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,国家药监局进行飞行检查后发现该公司伪造生产数据并违反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.

国家药监局已要求该公司所在的吉林省食品药品监督管理局撤销长春长生药品GMP证书,该证书是国际公认的药品生产许可证。

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.

国家药监局表示,参与检验的一批狂犬病疫苗尚未投放市场,并已得到有效控制。国家和省食品药品监督管理局已派出检查员驻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.

长春长生的母公司是于深圳上市的长生生物科技有限公司,该公司已经公开道歉,并自愿召回市场上出售的所有狂犬病疫苗。

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.

该公司表示,召回将花费超过2亿元(约3000万美元)。长生生物科技公司董事会秘书赵春志告诉《中国证券报》,狂犬病疫苗产品的销售收入占长春长生总收入的一半。

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.

这不是长生生物技术及其子公司首次涉足药品安全丑闻。7月18日,吉林省食品药品监督管理局公布了对长春长生DTaP疫苗的调查结果。

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,一批针对百日咳、白喉和破伤风免疫儿童的疫苗被发现不符合生物效价标准。根据这份报告,这批疫苗中有252600种已经销售到整个中国东部山东省的疾病控制和预防中心。

(英文来源:CGTN;英语俱乐部独家编译)

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