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SFDA Officially Kicks Off Safety Reappraisal Of TCM Injections

This article was originally published in PharmAsia News

Executive Summary

China's State FDA has officially started reappraising the safety of TCM injections (PharmAsia News, July 22, 2009). Of the total 143 products, Shuanghuanglian and Shenmai injections are listed as the first batch for reassessment. SFDA officials said that the agency will focus on safety assurance and carry out the work on three levels - risk inspection, comprehensive evaluation and standards elevation. The agency will conduct risk assessments on major TCM injections by stages and groups. In addition, medicine producers must conduct risk assessments themselves during their production process for quality control. SFDA will prioritize and accelerate the raising of national TCM injection quality by issuing the standards in batches. (Click here for more - Chinese language)

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