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Drug inspections and approvals to be tougher
CHINA will tighten inspection of pharmaceuticals to improve drug safety and prevent corruption in the approval process, said a senior official who disclosed his agency has revoked licenses of 353 medicines over the last six months.
Wu Zhen, deputy director of the State Food and Drug Administration, said yesterday 3,049 applications for new drugs have been turned down since last August.
During an online interview, carried by the central government's Website, Wu said his administration is requiring officials to inspect pharmaceutical production facilities to ensure drugs are in accordance with their applications.
"Those who fail to meet standards will have their license revoked," Wu said.
He said the administration last year "effectively" handled 14 health hazards caused by bogus drugs including the case of Qiqihar fake Armillarisin A injection that killed 11 people and the case of Xinfu antibiotic that killed at least 10.
Another 17 health crises concerning substandard production facilities were investigated.
Wu said this year "will be critical" and the SFDA seeks to eliminate major health crisis caused by tainted food and drugs. "The task for all SFDA staff is arduous; the responsibilities are big ... We can do the work," Wu said.
In late January, China ordered an investigation into allegations that former SFDA chief 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.
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