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SFDA To Establish Early Warning System For Drugs

This article was originally published in PharmAsia News

Executive Summary

China State FDA will establish an early warning system as well as adopt coordinated steps to prevent or minimize harm to the public from adverse drug effects. Since setting up a notification procedure in 2001, the health care community and patients have been informed of 49 drugs with potential issues. SFDA will, according to the degree of risk, undertake five measures to supervise drugs with reported adverse reactions: (1) order drug producers to modify the product package inserts; (2) suspend the affected drugs' sale and use; (3) get drug manufacturers to improve production techniques; (4) convert OTC to prescription drugs; and (5) demand the drugs to be withdrawn from the market. (Click here for more - Chinese Language)

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