中药上市后安全性医院集中监测技术规范(征求意见稿)
8. The First Affiliated Hospital of Henan University of Traditional Chinese Medicine， Zhengzhou 450000， China；
9.Guangzhou Provincial Hospital of Chinese Medicine， Guangzhou 510120， China；
10.Jiangsu Province Hospital of Traditional Chinese Medicine， Nanjing 210029， China；
11.The Affiliated Hospital of Shandong University of Traditional Chinese Medicine， Jinan 250011， China；
12.The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine， Chengdu 610072， China)
[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.
[Key words] post-marketing Chinese medicine； parenterally administered Chinese medicine； safety； intensive hospital monitoring； technical specifications
doi：10.4268/cjcmm20131801, 百拇医药(谢雁鸣 廖星 赵玉斌 黎明全 张允岭 马融 冼绍祥 刘健 李素云 温泽淮 杨忠奇)
9.Guangzhou Provincial Hospital of Chinese Medicine， Guangzhou 510120， China；
10.Jiangsu Province Hospital of Traditional Chinese Medicine， Nanjing 210029， China；
11.The Affiliated Hospital of Shandong University of Traditional Chinese Medicine， Jinan 250011， China；
12.The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine， Chengdu 610072， China)
[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.
[Key words] post-marketing Chinese medicine； parenterally administered Chinese medicine； safety； intensive hospital monitoring； technical specifications
doi：10.4268/cjcmm20131801, 百拇医药(谢雁鸣 廖星 赵玉斌 黎明全 张允岭 马融 冼绍祥 刘健 李素云 温泽淮 杨忠奇)