China’s Drug Regulator Tightens Industry Further
China’s Xinhua news agency reported on the 29th October that a new measure to raise the quality of the country’s pharmaceutical products is set to be implemented. The move follows a succession of drug-related fatalities and other serious side effects, with the new rule to be put in operation from January 1st 2008. It will make more stringent the current regulation through which, presently, a drug manufacturer is provided with a licence if three product-defects are discovered, but only if they are rectified. From the beginning of next year, this will be tightened with the result that no “severe defects” will be permitted in any instance.
The Chinese State Food and Drug Administration’s Bian Zhenjia described the rule-amend as having “...strengthened supervision over weak links in quality control of drug manufacturers."
In respect of what constitutes a “severe defect”, the report provided one example of when drug firms provide information which is false, but did not elaborate further.
Drug Industry Overhaul in China After String of Incidents
China’s government has spent much of 2007 putting the drug industry through a major overhaul – with an emphasis on areas of licensing and regulation – in light of a series of well-publicised incidents. In July, a former director of the SFDA was executed after he was found to have accepted bribes in return for approving new, un-trialled drugs. Five months earlier, the government had demanded a review be carried out to assess the legality of the 170,000 licences given during his period in power
Most recently, the Chinese government was understood to be putting into law another reform, on which terms Chinese drug manufacturers would be obliged to finance their own product recalls if the situation demanded.
Pharmaceutical International will continue to report on the latest developments within the Chinese pharmaceutical industry as we get the facts.
Source – Pharmaceutical International’s Far East Correspondent
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