Agreement With China to Regulate Some Drugs
中美达成协议，加强药品监管
BEIJING — American and Chinese regulators signed an agreement Tuesday to strengthen regulation of drugs and medical devices exported to the United States. But the accord covers only a tiny fraction of the pharmaceutical ingredients being marketed worldwide by thousands of unlicensed chemical companies.
北京—中美两国的药品监管部门在周二签署了一项协议来加强对出口到美国的药品和医疗器械的监管。但是这个协定只是覆盖了数千家向全世界出口药物成分的无证化工企业中的一小部门。
The agreement, one of a series of trade accords signed Tuesday, followed nearly seven months of negotiations, during which American officials asked China to stop unlicensed chemical companies from exporting bulk pharmaceutical ingredients, some of which were ending up in the United States.
这项协定是周二签署的众多贸易协定中的一份。为此中美双方进行了长达7个月的谈判，期间美国官员曾要求中方阻止未通过药品监管部门的化工企业向国外大批出口药物成分（其中一些的最终目的地是美国）。
In recent weeks, Chinese officials signaled that they were at least willing to consider the problem, acknowledging for the first time that gaps in that country’s regulatory system had allowed chemical companies to sell drug ingredients that might be substandard and dangerous.
最近几周的情况显示中国官员至少已经在考虑这个问题，他们第一次认识到这个国家监管上的漏洞使得化工企业可以销售药物成分，而这显然是不合理的和危险的。
“The illegal use of chemical ingredients as pharmaceutical ingredients has been a direct cause of cases of counterfeit and substandard medicine,” Vice Premier Wu Yi, who heads a campaign to improve the safety of exports, said two weeks ago.
国务院副总理吴仪（中国改善出口产品安全运动的领导者）在两周以前说：“非法的将化学成分当作药物成分来使用是产生伪劣药品的一条直接原因。”
Under the accord, all Chinese companies that make certain drug products for export to the United States will be required to register with Chinese regulators. Among the most important of those drugs are atorvastatin, the generic name for the cholesterol-lowering drug Lipitor; sildenafil, the generic name for Viagra; and the antibiotic gentamicin sulfate.
根据已经签署的协定，所有将药物出口到美国的中国公司都被要求到中国的药品监管部门注册。这里面最重要的几种药品包括：阿托伐他汀（辉瑞降低胆固醇药物利普妥的通用名）、sildenafil（伟哥的通用名）和硫酸庆大霉素。
American officials said that while the accord was limited, it was an important first step in helping the Chinese government regulate these unlicensed companies.
美国官员表示虽然这个协议的作用还是很有限的，但是它也表明中国政府在加强对未经药品监管部门审计的企业的监管方面迈出了非常重要的第一步。
In May, The New York Times first reported that an uncertified chemical company in China had sold a toxic ingredient, diethylene glycol, that was later mixed into cold and fever medicine, killing over 100 people in Panama.
今年5月，《纽约时报》首先报道一家没有药品生产资格的中国企业销售了一种有毒成分二甘醇，此后这种物质被掺入退烧药中，导致100名以上的巴拿马人死亡。
The diethylene glycol, a poisonous ingredient in some antifreeze, was substituted for glycerin, its safe but more expensive chemical cousin. Glycerin is one of the substances covered by the new accord.
二甘醇是一种有毒物质（作为一种防冻剂被使用）但是在巴拿马案中它代替了甘油（一种安全但是更昂贵的化学物质）。这次签定的新协定中也包含了对甘油出口的监管。
The Panama case was one reason that Michael O. Leavitt, secretary of health and human services, began reaching out to the Chinese in the hope of signing an agreement to tighten the oversight of chemical companies in China. Around the same time, Chinese manufacturers were found to be using diethylene glycol to make toothpaste, prompting more than 30 countries to recall the tainted products.
巴拿马案成为促使美国健康与公众服务部长Michael O. Leavitt尝试与中国签定一项协定，以加强对中国化工企业监管的原因之一。与此同时中国的制造商被发现在生产药膏的过程中使用了二甘醇，导致30多个国家下令召回这些受污染的产品。
Because chemical companies are not required to meet even minimal drug-manufacturing standards, there has been little to stop them from exporting unapproved, adulterated or counterfeit ingredients — some of which are sent to the United States.“It is unclear which can produce drug ingredients and which cannot,” Ms. Wu said.
尽管化工企业的生产达不到药品生产的最低标准，但是它们却可以不受阻止的出口那些未经批准的伪劣药物成分—其中一些被销售到了美国。吴仪女士也承认：“是否能够生产药物成分并没有清晰的标准。”
In late May, Mr. Leavitt’s agency announced that it had asked the Chinese government to regulate chemical companies that export pharmaceutical ingredients. Regulators here acknowledge they do not know how many unlicensed chemical companies sell pharmaceutical ingredients. The Times found 82 such companies at a trade show in Milan in October and more than 1,300 chemical companies selling drug ingredients over major business-to-business Internet trading sites.
今年5月底，美国健康与公众服务部宣布它已经要求中国加强对化工企业出口药物成分的监管。中国的监管部门却承认他们连中国到底有多少家无证销售药物成分的化工企业都不知道。《纽约时报》在米兰药物成分交易会上发现有82家化工企业参展而且有1300家以上的化工企业在通过互联网向国际市场销售药物成分。
“We take these problems that have appeared concerning chemicals very seriously,” Wu Zhen, a senior drug agency official, said at a news conference last week. Pharmaceutical companies are regulated by the food and drug agency. Chemical companies that make products like fertilizer are overseen by other agencies that do not specialize in drug making. With so many small chemical companies across China, it is unclear whether regulators have the resources to stop unlicensed companies from producing and exporting drug ingredients.
SFDA的高级官员Wu Zhen在上周的新闻发布会上表示：“我们已经认识到这些问题与化工企业紧密相关。”制药企业被SFDA监管，生产化肥等化工产品而不专门生产药品的企业被其他部门监管。整个中国有太多的小化工厂，很难说中国的监管部门有足够的资源阻止那些没有许可证的企业生产和出口药物成分。
In July 2006, the State Council, or cabinet, began a campaign to stamp out counterfeiters after a drug tainted with a toxic chemical killed at least 18 people here. Since then, the Chinese authorities have destroyed over 900 counterfeit drug operations and brought criminal charges against 279 people, Mr. Wu said.
Wu先生说：在发生了1起受有毒化学物质污染的药品造成18人死亡的事件以后，中国国务院开始了一项打击伪劣药品的行动，已经捣毁了900条伪劣药品生产线，有279人因此被判有罪。
中美达成协议，加强药品监管
BEIJING — American and Chinese regulators signed an agreement Tuesday to strengthen regulation of drugs and medical devices exported to the United States. But the accord covers only a tiny fraction of the pharmaceutical ingredients being marketed worldwide by thousands of unlicensed chemical companies.
北京—中美两国的药品监管部门在周二签署了一项协议来加强对出口到美国的药品和医疗器械的监管。但是这个协定只是覆盖了数千家向全世界出口药物成分的无证化工企业中的一小部门。
The agreement, one of a series of trade accords signed Tuesday, followed nearly seven months of negotiations, during which American officials asked China to stop unlicensed chemical companies from exporting bulk pharmaceutical ingredients, some of which were ending up in the United States.
这项协定是周二签署的众多贸易协定中的一份。为此中美双方进行了长达7个月的谈判，期间美国官员曾要求中方阻止未通过药品监管部门的化工企业向国外大批出口药物成分（其中一些的最终目的地是美国）。
In recent weeks, Chinese officials signaled that they were at least willing to consider the problem, acknowledging for the first time that gaps in that country’s regulatory system had allowed chemical companies to sell drug ingredients that might be substandard and dangerous.
最近几周的情况显示中国官员至少已经在考虑这个问题，他们第一次认识到这个国家监管上的漏洞使得化工企业可以销售药物成分，而这显然是不合理的和危险的。
“The illegal use of chemical ingredients as pharmaceutical ingredients has been a direct cause of cases of counterfeit and substandard medicine,” Vice Premier Wu Yi, who heads a campaign to improve the safety of exports, said two weeks ago.
国务院副总理吴仪（中国改善出口产品安全运动的领导者）在两周以前说：“非法的将化学成分当作药物成分来使用是产生伪劣药品的一条直接原因。”
Under the accord, all Chinese companies that make certain drug products for export to the United States will be required to register with Chinese regulators. Among the most important of those drugs are atorvastatin, the generic name for the cholesterol-lowering drug Lipitor; sildenafil, the generic name for Viagra; and the antibiotic gentamicin sulfate.
根据已经签署的协定，所有将药物出口到美国的中国公司都被要求到中国的药品监管部门注册。这里面最重要的几种药品包括：阿托伐他汀（辉瑞降低胆固醇药物利普妥的通用名）、sildenafil（伟哥的通用名）和硫酸庆大霉素。
American officials said that while the accord was limited, it was an important first step in helping the Chinese government regulate these unlicensed companies.
美国官员表示虽然这个协议的作用还是很有限的，但是它也表明中国政府在加强对未经药品监管部门审计的企业的监管方面迈出了非常重要的第一步。
In May, The New York Times first reported that an uncertified chemical company in China had sold a toxic ingredient, diethylene glycol, that was later mixed into cold and fever medicine, killing over 100 people in Panama.
今年5月，《纽约时报》首先报道一家没有药品生产资格的中国企业销售了一种有毒成分二甘醇，此后这种物质被掺入退烧药中，导致100名以上的巴拿马人死亡。
The diethylene glycol, a poisonous ingredient in some antifreeze, was substituted for glycerin, its safe but more expensive chemical cousin. Glycerin is one of the substances covered by the new accord.
二甘醇是一种有毒物质（作为一种防冻剂被使用）但是在巴拿马案中它代替了甘油（一种安全但是更昂贵的化学物质）。这次签定的新协定中也包含了对甘油出口的监管。
The Panama case was one reason that Michael O. Leavitt, secretary of health and human services, began reaching out to the Chinese in the hope of signing an agreement to tighten the oversight of chemical companies in China. Around the same time, Chinese manufacturers were found to be using diethylene glycol to make toothpaste, prompting more than 30 countries to recall the tainted products.
巴拿马案成为促使美国健康与公众服务部长Michael O. Leavitt尝试与中国签定一项协定，以加强对中国化工企业监管的原因之一。与此同时中国的制造商被发现在生产药膏的过程中使用了二甘醇，导致30多个国家下令召回这些受污染的产品。
Because chemical companies are not required to meet even minimal drug-manufacturing standards, there has been little to stop them from exporting unapproved, adulterated or counterfeit ingredients — some of which are sent to the United States.“It is unclear which can produce drug ingredients and which cannot,” Ms. Wu said.
尽管化工企业的生产达不到药品生产的最低标准，但是它们却可以不受阻止的出口那些未经批准的伪劣药物成分—其中一些被销售到了美国。吴仪女士也承认：“是否能够生产药物成分并没有清晰的标准。”
In late May, Mr. Leavitt’s agency announced that it had asked the Chinese government to regulate chemical companies that export pharmaceutical ingredients. Regulators here acknowledge they do not know how many unlicensed chemical companies sell pharmaceutical ingredients. The Times found 82 such companies at a trade show in Milan in October and more than 1,300 chemical companies selling drug ingredients over major business-to-business Internet trading sites.
今年5月底，美国健康与公众服务部宣布它已经要求中国加强对化工企业出口药物成分的监管。中国的监管部门却承认他们连中国到底有多少家无证销售药物成分的化工企业都不知道。《纽约时报》在米兰药物成分交易会上发现有82家化工企业参展而且有1300家以上的化工企业在通过互联网向国际市场销售药物成分。
“We take these problems that have appeared concerning chemicals very seriously,” Wu Zhen, a senior drug agency official, said at a news conference last week. Pharmaceutical companies are regulated by the food and drug agency. Chemical companies that make products like fertilizer are overseen by other agencies that do not specialize in drug making. With so many small chemical companies across China, it is unclear whether regulators have the resources to stop unlicensed companies from producing and exporting drug ingredients.
SFDA的高级官员Wu Zhen在上周的新闻发布会上表示：“我们已经认识到这些问题与化工企业紧密相关。”制药企业被SFDA监管，生产化肥等化工产品而不专门生产药品的企业被其他部门监管。整个中国有太多的小化工厂，很难说中国的监管部门有足够的资源阻止那些没有许可证的企业生产和出口药物成分。
In July 2006, the State Council, or cabinet, began a campaign to stamp out counterfeiters after a drug tainted with a toxic chemical killed at least 18 people here. Since then, the Chinese authorities have destroyed over 900 counterfeit drug operations and brought criminal charges against 279 people, Mr. Wu said.
Wu先生说：在发生了1起受有毒化学物质污染的药品造成18人死亡的事件以后，中国国务院开始了一项打击伪劣药品的行动，已经捣毁了900条伪劣药品生产线，有279人因此被判有罪。