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Chinese drug safety programme progresses

China's campaign to increase safety in marketed drugs is making progress, according to the State Food and Drug Administration

China's campaign to increase safety in marketed drugs is making progress, according to a press statement by the State Food and Drug Administration (SFDA).

The state-run agency has said that since the new rules were introduced in July 2007 and over 7,300 pharmaceutical companies have withdrawn applications for drug approval since then.

The SFDA added that it was working to restore its reputation after its previous director was executed in the summer on charges he took bribes to approve untested medications, which resulted in death and injury of domestic and foreign patients. The revelation damaged China's international reputation enormously.

The 7,300 withdrawn applications account for 24 per cent of those investigated.

To combat violations by domestic pharmaceutical companies, the SFDA has improved drug registration and increased checks on the quality of manufacturing and marketing of drugs.

Approximately 180 drugs have been banned from sale due to false advertisements, according to Wu Zhen, deputy commissioner of the SFDA. In addition, 300 drug and medical device manufacturers have been closed down for producing inferior-quality products.

Wu said at a press conference: "The withdrawals have shown that the pharmaceutical companies are examining themselves in this special campaign and their awareness for drug safety has been greatly enhanced.î

However, the issue of counterfeit drugs in the region remains, with 1,100 approved drugs later found to have safety issues. As a result, hundreds of illegal manufacturing sites have been closed down, according to the SFDA.

Wu said China has exercised "stringent management" of its pharmaceutical exports, with only approved companies allowed to export their products. He added that any export problems lie with the importers who do not have strict enough rules and regulations.

The SFDA is also trying to promote proper drug use by increasing public awareness of how to take drugs, which are reportedly over-prescribed in China's privatised health system.

4th December 2007

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