（雙語(yǔ)新聞） 中國(guó)第二大狂犬病疫苗制造商停止生產(chǎn)

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

希尼爾翻譯公司（www.marshallsfreshproduce.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(guó)食品藥品監(jiān)督管理局( CFDA )發(fā)布公告，要求中國(guó)第二大狂犬病疫苗制造商長(zhǎng)春長(zhǎng)生生命科學(xué)公司停止生產(chǎn)Vero細(xì)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(dāng)局進(jìn)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(guó)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(guó)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(xiāo)長(zhǎng)春長(zhǎng)生藥品生產(chǎn)國(guó)際認(rèn)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(chǎng)，并已得到“有效控制”。國(guó)家食品藥品監(jiān)督管理局和省級(jí)食品藥品管理局的檢查員一直在這家公司進(jìn)行進(jìn)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(zhǎng)春長(zhǎng)生的母公司、在深圳上市的長(zhǎng)生生物技術(shù)有限公司(Changsheng Biotechnology)已公開(kāi)道歉，并主動(dòng)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(fèi)公司業(yè)務(wù)收入的2億元人民幣(約3000萬(wàn)美元)。常勝生物技術(shù)公司總裁秘書(shū)趙春志告訴《中國(guó)證券報(bào)》，狂犬病疫苗產(chǎn)品的銷(xiāo)售收入占長(zhǎng)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(zhǎng)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(zhǎng)春長(zhǎng)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(duì)抗百日咳、白喉和破傷風(fēng)的疫苗被發(fā)現(xiàn)不符合生物效力標(biāo)準(zhǔn)。根據(jù)該報(bào)告，這批疫苗中有252，600種已經(jīng)賣(mài)給了中國(guó)東部山東省的疾病控制和預(yù)防中心。

來(lái)源:中國(guó)國(guó)際電視臺(tái)