因原料葯檢出極微量基因毒性雜質，華海葯業深陷「毒素門」
隨著基因毒性雜質法規的逐步健全，葯監部門對基因毒性雜質的監管要求越來越高，必須引起大家的高度重視。
公眾號往期推薦：【收藏】基因毒性雜質的法規技術要求與質控策略（點擊可直接跳轉）
或公眾號回復：「基因毒性雜質」獲取意想不到的資料。
事件回顧
7月5日，歐洲藥品管理局（EMA）發布召回公告稱，正在審查含有纈沙坦活性物質的藥物。這次審查，是因為華海葯業在提供給歐洲市場的部分纈沙坦製劑的原料葯中意外發現基因毒性雜質N-亞硝基二甲胺(NDMA)。纈沙坦藥物用於治療高血壓，以減少心臟病發作和中風等併發症，它也用於心力衰竭或近期心臟病發作的患者。根據實驗室測試的結果，被發現的雜質NDMA被歸類為可能的人類致癌物。
EMA稱，將調查這些纈沙坦藥物中NDMA的水平，以及對服用該藥物的患者可能產生的影響，以及可以採取哪些措施來減少或消除公司生產的未來批次中的雜質。此外，德國、義大利、芬蘭、奧地利、日本也相繼發布了召回公告，召回含有華海葯業提供的纈沙坦原料葯的製劑。
EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity
在檢測到雜質後，EMA正在審查含有來自浙江華海葯業纈沙坦的藥物
時間 | July 05, 2018
來源 | EMA
編譯 | Tony
Some valsartan medicines being recalled across the EU
一些纈沙坦藥物正被歐盟召回
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
歐洲藥品管理局（EMA）正在審查含有纈沙坦活性物質的藥物，該原料葯由位於中國臨海市的浙江華海葯業提供。
The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance which the company supplies to manufacturers producing some of the valsartan medicines available in the EU.
這項審查是在該公司檢測到纈沙坦原料葯中含有N-亞硝基二甲胺（NDMA）雜質引發的，該公司為一些歐洲生產纈沙坦藥物的製造商提供原料葯。
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
根據實驗室測試的結果，NDMA被歸類為可能的人類致癌物（一種可能導致癌症的物質）。 NDMA的存在是出乎意料的，並且被認為與活性物質的製造方式的變化有關。
While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.
在審查期間，歐盟各國政府正在召回由浙江華海提供的含有纈沙坦的藥物。
Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack.
纈沙坦類藥物用於治療高血壓患者，以減少心臟病和中風等併發症。它也用於心臟衰竭或近期心臟病發作的患者。
EMA』s review will investigate the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. As a precaution, the review will also consider whether other valsartan medicines may be affected.
EMA的審查將調查這些纈沙坦藥物中NDMA的水平，其對服用這些藥物的患者可能產生的影響，以及採取什麼措施來減少或消除公司生產的未來批次中的雜質。作為預防措施，審查也將考慮其他纈沙坦藥物是否會受到影響。
The review will be carried out by EMA』s Committee for Medicinal Products for Human Use (CHMP).
審查將由EMA的人類藥物產品委員會（CHMP）進行。
N-nitrosodimethylamine (NDMA) has been detected in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals.
浙江華海製藥生產的纈沙坦活性物質已檢測到N-亞硝基二甲胺（NDMA）。
As a result, valsartan medicines containing the active substance from Zhejiang Huahai are being recalled in the EU.
因此，來自浙江華海葯業的纈沙坦原料葯在歐盟被召回。
National authorities are contacting pharmacists with information on the medicines to be recalled.
國家當局正在與藥劑師聯繫有關召回藥品的信息。
EMA is now evaluating potential impact on patients of the exposure to NDMA in valsartan medicines. Further information will be provided once available.
EMA目前正在評估對NDMA患者服用纈沙坦藥物的潛在影響。一旦可用，將提供進一步的信息。
Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.
纈沙坦是一種血管緊張素II受體拮抗劑，用於治療高血壓、早期的心臟病發作和心力衰竭。它可以單獨使用，也可以與其他活性物質聯合使用。
The review covers all medicines that contain valsartan supplied by Zhejiang Huahai Pharmaceuticals. As a precaution, the review will also consider whether other valsartan medicines may be affected.
該審查涵蓋了所有含有浙江華海葯業公司提供的纈沙坦的藥物。作為預防措施，審查還將考慮其他纈沙坦藥物是否會受影響。
Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products
Prinston製藥公司在全國範圍內對纈沙坦和纈沙坦HCTZ片產品進行召回，原因是在產品中發現了微量的出乎意料的雜質，N-亞硝基二甲胺（NDMA）
時間 | July 13, 2018
來源 | FDA
編譯 | Tony
Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level.
Prinston製藥公司的dba Solco醫療保健公司正在召回所有批次的纈沙坦片，規格包括40毫克，80毫克，160毫克和320毫克; 和纈沙坦 - 氫氯噻嗪片，規格包括80mg / 12.5mg，160mg / 12.5mg，160mg / 25mg，320mg / 12.5mg，和320mg / 25mg，產品至零售層面召回。
This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
此產品召回是由於原料葯製造商浙江華海葯業有限公司檢測到微量的基因毒性雜質, N-亞硝基二甲胺(NDMA),該原料藥用於生產主題產品批次。根據國際癌症研究機構分類, 這種雜質被歸類為可能的人類致癌物質
The products are indicated for the treatment of hypertension.
該產品用於治療高血壓。
The exposure to the impurity N-nitrosodimethylamine (NDMA) that was detected in valsartan product line presents an unacceptable carcinogenic risk to the intended patient population. To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.
在纈沙坦生產線上檢測到的雜質N-亞硝基二甲胺（NDMA）對預期的患者人群造成了不可接受的致癌風險。到目前為止，Prinston製藥公司還沒有收到任何與這次召回有關的不良事件的報告。
華海葯業關於纈沙坦原料葯的未知雜質中發現極微量基因毒性雜質的公告
If you are interested in pharmaceutical industry, if you"ve already known the industry well, welcome to join us. 如果您立志在醫藥行業發展, 如果您已在此行業身經百戰, 歡迎加入我們的行列. We are Tony, Rona, Aaron, Vivian, Effy, Brynn...(Your Name)
TAG:葯事谷 |