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China: 2011 Adverse Reaction Report Released

Regulatory Update | Posted: 1 June 2012

By Louise Zornoza, RegLink

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China’s State Food and Drug Administration (SFDA) has released a report detailing the adverse event reports it received during 2011. The report notes events involving anti-infective medicines accounted for the higher number of reports, including cephalosporins (34.8%), penicillin (14%) and quinolones (12.2%).

New and serious adverse drug reactions accounted for 17.1% of the total number of reports. Medical institutions were the primary source for such reports, accounting for about 83% of all reported events.

2011 adverse reactions report

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