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China persists with pharma reforms

By Kirsty Barnes , 06-Sep-2007

China has confirmed the target areas of planned sweeping pharmaceutical industry reforms and also handed down the latest in a string of sentences to corrupt former drug officials.

The country's State Food and Drug Administration (SFDA) has said it will place a particular emphasis on the scrutiny of the manufacturing of injectable drug products by upping the number of its staff at such production sites. Injectable drugs are particularly sensitive to contamination and carry greater safety risks than drugs delivered by other methods and so the agency said it plans to take particular care to ensure that the formulation and ingredients and production techniques for these drugs adhere to good manufacturing practice (GMP). In addition, the agency will crack down on wholesalers and distributors of pharmaceutical ingredients, checking the licenses of anyone who started operating as of 2006, and will also carefully monitor those involved at all stages of the supply chain of highly restricted substances, according to news agency Interfax China. Meanwhile, the latest in a string of former drug officials has been sentenced by a Chinese court for corruption. Zheng Shangjin, ex-head of the Food and Drug Administration in Zhejiang province, was sentenced to four years in prison, it was reported by China's Xinhua news agency. During 2003 to 2006, Zheng received $13,245 in bribes and a car worth $76,821 from Zhejiang Kangliyuan Investment Group, the owner of owns several pharmaceutical companies who was awarded a Good Manufacturing Practice certificate by Zheng's agency in 2002 and was subsequently granted over 100 new drug certificates per year. According to Xinhua, the Zhejiang Kangliyuan group was later linked to other cases of corruption within the SFDA, the most high profile being that of Zheng Xiaoyu, the former director of the SFDA after he was convicted of corruption in the drug approval process, which ultimately led to the death of Chinese citizens after substandard products reached the market. He was sentenced to death and subsequently executed in June. His former colleague Cao Wenzhuan was also handed a similar fate although his death sentence has been suspended for two years and will be most likely commuted to life in prison. Many other senior officials have or are also likely to receive lengthy jail terms as prosecutions continue.


Meanwhile, as part of the SFDA's latest campaign of action, all of the drugs who applied for and/or received marketing approval between January 2005 and August 2006 will now have to undergo on-site inspections by the regulator.

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