[Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].
Traditional 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.
Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China. md_wanghainan@yahoo.com.cn
Hai-Nan
HN
Wang
Wen
W
Chen
Zheng
Z
Fu
Wen-min
WM
Du
Jia
J
He
D016907:Adverse Drug Reaction Reporting Systems; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects*; D007267:Injections / Q000009:adverse effects* / Q000379:methods*; D008516:Medicine, Chinese Traditional / Q000009:adverse effects* / Q000379:methods*
D004365:Drugs, Chinese Herbal