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China Considers 24-Hour Deadline for Recall of Seriously Harmful Drugs (China)

This article was originally published in PharmAsia News

Executive Summary

In the wake of major recalls for two leukemia drugs, China's State Food and Drug Administration is drafting new rules for pharmaceutical manufacturers who suspect there may be a problem with their products. Under the new plan, recalled drugs would be grouped into three categories. In the first category are drugs that could have deadly or permanent effects. These drugs must be recalled within 24 hours. The second category includes drugs that could cause temporary damage and must be recalled within three days. The third category is reserved for labeling mistakes or other minor issues. Manufacturers would have seven days to enact these kinds of recalls. Chinese officials are still finalizing consequences for pharmaceutical companies found violating these rules. Proposed punishments include fines up to 50,000 yuan or the revocation of the company's production license. (Click here for more



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