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首页>>Important news>>In This Issue>>本页

Watchdog revises drug regulations
    2007年03月12日    

CHINA’S drug watchdog is revising the existing drug registration and management provisions and will put the new ones into effect this year.

The State Food and Drug Administration (SFDA) released the revised version Saturday to solicit public opinion.

“The new draft is focused on closing registration loopholes in existing provisions and encouraging research on new drugs,” said Wu Zhen, vice director general of the administration.

Several drug safety incidents occurred in China last year, the most notorious being the Xinfu drug by Anhui Huayuan Worldbest Biology Pharmacy Co. that caused six deaths in August.

China will tighten inspection of pharmaceuticals to improve drug safety and prevent corruption in the approval process, Wu said early in February.

In late January, China ordered an investigation into allegations that former chief of the SFDA Zheng Xiaoyu abused his position and took bribes in exchange for ignoring drug approval regulations.

“Corruption starts with the approval procedure, and a small number of officials bring shame to the entire drug watchdog team,” said Wu.

Wu said the administration will adopt a system, under which new drugs will require the approval of several officials instead of one. He said the agency will enhance staff accountability by putting approval procedures on the Internet.

Insiders said there was rampant corruption involving the SFDA after Zheng introduced the Good Medicine Product (GMP) certificate to replace local standards. By 2003, more than 2,000 drug producers had been awarded GMP certificates in China, compared with only 87 before 1999.

Vice Premier Wu Yi earlier admitted that the drug supervision system has severe loopholes, ranging from loose rules which could be changed by some officials to suit their own interests through to lax supervision.(Xinhua)


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