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Health Matters

Watchdog to Strengthen Inspection over GMP System

  China will strengthen inspection over drug companies covered by the certification system called Good Manufacturing Practice (GMP), which was brought into disrepute by a series of health scares and corruption scandals, said a senior drug watchdog official on Tuesday.

Wu Zhen, deputy director of the State Food and Drug Administration (SFDA), said the administration carried out numerous unannounced inspections of drug manufacturers last year and stripped 86 companies their GMP certificates.

"We will tighten the regular examinations of drug producers this year," Wu said.

"GMP is a good system and problems were caused by the companies' violations and a lack of supervision from the administration," Wu said.

The GMP system was promoted by Zheng Xiaoyu, former director of the SFDA, who is being investigated for abusing his position to take bribes in exchange for ignoring drug approval regulation.

Under the system, companies must possess a GMP certificate before they can register new medicines.

The most notorious case that hurt the credibility of GMP came to light last July when "Xinfu" antibiotic injections, manufactured by Anhui Huayuan Worldbest Biology Pharmacy Company, caused the deaths of at least six patients and severe reactions in more than 80 others.

Last November one of Zheng Xiaoyu's directors at the SFDA, Hao Heping, was sentenced to 15 years in prison for taking bribes.

Cao Wenzhuang, former director of the drug registration department of the SFDA, was detained in Jan. 2006 on suspicion of bribery.



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