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SFDA Tightens TCM Injection Regulations

This article was originally published in PharmAsia News

Executive Summary

China's State Food and Drug Administration recently released the basic technology requirements for traditional Chinese medicine and natural injection to tackle problems in TCM injection such as complicated chemical ingredients, poor preparation technology, shoddy standards, and undeterminate clinical effects. The new regulation requires TCM and natural product injection to identify their ingredients, with single-ingredient TCM injections attaining a purity level of 90 percent. It also seeks to regulate injections with altered route of administration or dosage and better guidelines for generic drugs. Besides imposing more control on non-clinical study and clinical trials, SFDA proposes a surveillance system on adverse drug reactions. Industry observers believe that the stricter regulations will raise TCM production safety and efficacy. (Click here for more
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