Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments).
- Author:
Yan-Ming XIE
1
;
Xing LIAO
1
;
Yu-Bin ZHAO
1
;
Ming-Quan LI
1
;
Yun-Ling ZHANG
2
;
Rong MA
3
;
Shao-Xiang XIAN
4
;
Jian LIU
5
;
Su-Yun LI
6
;
Ze-Huai WEN
7
;
Zhong-Qi YANG
4
;
Jian-Dong ZOU
8
;
Hong-Sheng SUN
9
;
Yan HE
10
;
Xue-Lin LI
6
;
Jun-Jie JIANG
1
;
Zhi-Fei WANG
1
;
Yuan-Yuan LI
1
;
Lian-Xin WANG
1
;
Yan-Peng CHANG
1
;
Wei YANG
1
;
Wen ZHANG
1
Author Information
- Publication Type:Journal Article
- MeSH: China; epidemiology; Drug Monitoring; adverse effects; standards; Drug-Related Side Effects and Adverse Reactions; epidemiology; etiology; Drugs, Chinese Herbal; adverse effects; standards; Hospital Information Systems; Humans; Product Surveillance, Postmarketing; methods; standards
- From: China Journal of Chinese Materia Medica 2013;38(18):2919-2924
- CountryChina
- Language:Chinese
- Abstract: It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus 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.
