SFDA Issues Labeling Revision On NSAlDs
This article was originally published in PharmAsia News
Executive Summary
China's State FDA has issued a notice on the prescribing information of nonsteroid anti-inflammatory drugs, demanding that drug manufacturers revise their drug prescribing information and labels, and notify relevant medical institutions and drug-handling enterprises of the amended content. Drug manufacturers have to track clinical safety information on their NSAlDs, monitor adverse drug reactions and report such incidents to authorities. The new supplementary information in the notice focuses on the possibility of NSAlDs causing cerebral, cardiovascular and gastrointestinal bleeding. The sales of NSAIDs, anti-inflammatory drugs and antirheumatic agents have dropped in China following adverse events linked to Vioxx. The latest revision may prove challenging for the industry but experts believe the market will grow due to the large pool of patients and stepped-up new drug launches. (Click here for more - Chinese Language)
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