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【技术产业】政府公布 18个使用亮菌甲素死亡病
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http://www.dxy.cn/bbs/post/view?bid=116&id=6243437&tpg=1&ppg=1&sty=1&age=0#6243437
翻译 / 刘昱攒
中国政府要求药物产品管理者建立完整的品管机制
中国政府当局报导了一个治疗胆囊与胃方面疾病的问题药物armillarisin A，至今已直接让9个使用它的病人死亡。该药物是由广州中山大学附属医院负责提供给病人作注射用。
中国政府官网上出现的这一条新闻，报导18个因使用armillarisin A而死的人里面，有9个因直接注射而死亡，其余的死于他因。
中国食品药物管理局 (China's State Food & Drug Administration, SFDA) 在5月18号发布了一份声明，要求所有州县与自治区层级的药物管理部门强制其药物制造过程的监督。SFDA认为药厂应该比照GMP (Good Manufacturing Practices) 认证系统，建立起产品质量验证机制。
一位有外国制药厂经验并熟悉中国药厂生态的经理私下告诉Chemical & Engineering News：其实，中国目前建立的GMP实施要点与现场检验流程，在他们的产品到达世界标准前，仍然有很长的路要走。
May 25, 2006
BUSINESS
More Deaths From Chinese Drug
Chinese government tells regulators to step up enforcement
Jean-François Tremblay
China's government reports that a faulty drug aimed at treating gall bladder and gastric conditions has now killed nine people. The injectable drug, armillarisin A, was administered to patients at a hospital affiliated with Sun Yat-sen University, in Guangzhou (C&EN, May 22, page 11).
A news item posted on the official website of the Chinese government reports that out of 18 people who died after receiving the drug, nine were killed by the injection. The others died from other causes.
China's State Food & Drug Administration issued a notice on May 18 requiring drug regulatory departments at the state and municipal levels to strengthen their supervision of drug manufacturers. SFDA also said that companies should "improve the product quality-assurance system according to the requirements of Good Manufacturing Practices."
An executive with a foreign manufacturer of pharmaceutical ingredients who is familiar with China’s drug industry tells C&EN that "it is well-known that the Chinese GMP guidelines and site inspections still need a lot of improvement before they can ensure product quality." [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-02-18 17:11
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