• Zhongguo Zhong Yao Za Zhi · Mar 2008

    [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    • Hai-Nan Wang, Wen Chen, Zheng Fu, Wen-min Du, and Jia He.
    • Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China. md_wanghainan@yahoo.com.cn
    • Zhongguo Zhong Yao Za Zhi. 2008 Mar 1; 33 (5): 612-4.

    AbstractTraditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

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