Expert consensus for postmarketing Chinese medicine intensive hospital safety monitoring

It is of vital significance to conduct active postmarketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China Food and Drug Administration. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug eve...

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Bibliographic Details
Published in:Chinese journal of integrative medicine 2014-07
Main Authors: Liao, Xing, Zhang, Wen, Xie, Yan-Ming, Tian, Feng, Zhao, Yu-Bin, Li, Ming-Quan, Zhang, Yun-Ling, Ma, Rong, Xian, Shao-Xiang, Liu, Jian, Li, Su-Yun, Wen, Ze-Huai, Yang, Zhong-Qi, Zou, Jian-Dong, Sun, Hong-Sheng, He, Yan, Li, Xue-Lin, Jiang, Jun-Jie, Wang, Zhi-Fei, Li, Yuan-Yuan, Wang, Lian-Xin, Chang, Yan-Peng, Yang, Wei
Format: Article
Language:English
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Summary:It is of vital significance to conduct active postmarketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China Food and Drug Administration. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The expert consensus for postmarketing surveillance focuses on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.
ISSN:1672-0415
1993-0402
DOI:10.1007/s11655-014-1838-y