China raises threshold for drug GMP certification

时间：2007-10-30 07:45:55

（单词翻译:单击）

Oct. 30 - In the wake of several drug production scandals the Chinese government has tightened1 up application procedures for firms seeking to manufacture drugs.

 

The threshold to qualify for a Good Manufacturing Practice (GMP) certification has been raised and will come into effect on Jan. 1 next year.

 

"The new standards are stricter in granting GMP certificates to drug manufacturers," said Bian Zhenjia, director with the drug safety supervision2 department under the State Food and Drug Administration (SFDA), China's drug watchdog.

 

Before revision, if less than three "severe defects" as defined in the standards were discovered in the entire drug making process, the manufacturers could still get a certificate if they corrected the problem within a prescribed time limit.

 

The new standards, however, allow no "severe defects" according to Bian.

 

"The new standards have strengthened supervision over weak links in quality control of drug manufacturers," Bian said.

 

The revised standards comprise 259 articles, an increase of 34 articles from the current standards which were put into effect in 1999.

 

And the "key" articles have been augmented3 from previous 56 to 92, according to Bian.

 

"The changes mainly dwell on technological4 requirements on management which concerns areas including personnel qualifications, production process, quality control and document verification in a bid to ensure drug quality," Bian explained.

 

The new standards also stipulate5 that companies falsifying application documents shall be regarded as having a "severe defect," meaning they will fail the GMP certification.

 
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点击收听单词发音收听单词发音  

1 tightened bd3d8363419d9ff838bae0ba51722ee9     
收紧( tighten的过去式和过去分词 )； （使）变紧； （使）绷紧； 加紧
参考例句：
  • The rope holding the boat suddenly tightened and broke. 系船的绳子突然绷断了。
  • His index finger tightened on the trigger but then relaxed again. 他的食指扣住扳机，然后又松开了。
2 supervision hr6wv     
n.监督，管理
参考例句：
  • The work was done under my supervision.这项工作是在我的监督之下完成的。
  • The old man's will was executed under the personal supervision of the lawyer.老人的遗嘱是在律师的亲自监督下执行的。
3 Augmented b45f39670f767b2c62c8d6b211cbcb1a     
adj.增音的 动词augment的过去式和过去分词形式
参考例句：
  • 'scientists won't be replaced," he claims, "but they will be augmented." 他宣称：“科学家不会被取代；相反，他们会被拓展。” 来自英汉非文学 - 科学史
  • The impact of the report was augmented by its timing. 由于发表的时间选得好，这篇报导的影响更大了。
4 technological gqiwY     
adj.技术的；工艺的
参考例句：
  • A successful company must keep up with the pace of technological change.一家成功的公司必须得跟上技术变革的步伐。
  • Today,the pace of life is increasing with technological advancements.当今， 随着科技进步，生活节奏不断增快。
5 stipulate shhyP     
vt.规定，（作为条件）讲定，保证
参考例句：
  • International rules stipulate the number of foreign entrants.国际规则规定了外国参赛者的人数。
  • Some manufacturers stipulate the price at which their goods are to be sold.有些制造商规定出售他们生产的商品的价格。

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