[Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments)].
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.
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yan-Ming
YM
Xie
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Xing
X
Liao
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yu-Bin
YB
Zhao
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Ming-Quan
MQ
Li
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
Yun-Ling
YL
Zhang
The First Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Rong
R
Ma
The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
Shao-Xiang
SX
Xian
The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, China.
Jian
J
Liu
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Su-Yun
SY
Li
Guangzhou Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.
Ze-Huai
ZH
Wen
The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
Zhong-Qi
ZQ
Yang
Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing 210029, China.
Jian-Dong
JD
Zou
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250011, China.
Hong-Sheng
HS
Sun
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.
Yan
Y
He
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Xue-Lin
XL
Li
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Jun-Jie
JJ
Jiang
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhi-Fei
ZF
Wang
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yuan-Yuan
YY
Li
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Lian-Xin
LX
Wang
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yan-Peng
YP
Chang
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Wei
W
Yang
Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Wen
W
Zhang
D002681:China / Q000453:epidemiology; D016903:Drug Monitoring / Q000009:adverse effects / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000592:standards*; D006751:Hospital Information Systems; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*
D004365:Drugs, Chinese Herbal