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Flaws In China’s Drug Regulatory Process Revealed In Herbal Injection Recall

This article was originally published in PharmAsia News

Executive Summary

China's Ministry of Health and State FDA have issued an urgent notice to recall two batches of Ciwujia injection produced by Wandashan Pharmaceutical after adverse effects resulting in three deaths were reported. Although the investigation is still ongoing, experts think that the deaths were mainly caused by impurities in the herbal injection. For food and drug supervision, China currently only tests active components. Control is lax on impurities testing; furthermore, the complex nature of traditional Chinese medicine components means some impurities cannot be detected. Industry analysts observe that despite the country's repeated adverse drug incidents, the negative impact on TCM injections will probably be short term as the products still have big market potential due to their low cost. (Click here for more - Chinese Language)

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