青島希尼爾翻譯公司（www.googlemapbuilder.com）整理發(fā)布2018-07-24

希尼爾翻譯公司（www.googlemapbuilder.com）2018年7月24日了解到：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.

中國食品藥品監(jiān)督管理局( CFDA )發(fā)布公告，要求中國第二大狂犬病疫苗制造商長春長生生命科學公司停止生產(chǎn)Vero細胞狂犬病疫苗。

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，當局進行了突擊檢查，發(fā)現(xiàn)該公司偽造生產(chǎn)數(shù)據(jù)，違反了國家藥品生產(chǎn)質(zhì)量管理協(xié)議。

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.

國家食品藥品監(jiān)督管理局已要求公司所在地吉林省食品藥品監(jiān)督管理局吊銷長春長生藥品生產(chǎn)國際認可許可證(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，參與檢查的那批狂犬病疫苗尚未投放市場，并已得到“有效控制”。國家食品藥品監(jiān)督管理局和省級食品藥品管理局的檢查員一直在這家公司進行進一步調(diào)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.

長春長生的母公司、在深圳上市的長生生物技術(shù)有限公司(Changsheng Biotechnology)已公開道歉，并主動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.

該公司表示，此次召回將花費公司業(yè)務(wù)收入的2億元人民幣(約3000萬美元)。常勝生物技術(shù)公司總裁秘書趙春志告訴《中國證券報》，狂犬病疫苗產(chǎn)品的銷售收入占長春常勝總收入的一半。

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.

這并不是長生生物科技公司及其附屬公司第一次卷入藥品安全丑聞。7月18日，吉林省食品藥品監(jiān)督管理局公布了長春長勝DTaP疫苗的調(diào)查結(jié)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，一批免疫兒童對抗百日咳、白喉和破傷風的疫苗被發(fā)現(xiàn)不符合生物效力標準。根據(jù)該報告，這批疫苗中有252，600種已經(jīng)賣給了中國東部山東省的疾病控制和預(yù)防中心。

來源:中國國際電視臺