Expert consensus on the design and implementation of clinical safety centralized monitoring study of Chinese medical injection.

Jun-Hua ZHANG; Jing-Tian REN; Jing-Qing HU; Yan-Ming XIE; Hai-Bo SONG; Ming-Jun ZHU; Rui GAO; Zhong WANG; Wen-Ke ZHENG; Xue-Lin LI; Meng JIANG; Yu-Hong HUANG; Fang LU; Li-Yun HE; Wei-Xiong LIAN; Zhong-Qi YANG; Wei-An YUAN; Si-Yuan HU; Bao-He WANG; Wei-Liang WANG; De-Quan REN; Bo-Li ZHANG; null; null

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Expert consensus on the design and implementation of clinical safety centralized monitoring study of Chinese medical injection.

Author: Jun-Hua ZHANG ¹ ; Jing-Tian REN ² ; Jing-Qing HU ³ ; Yan-Ming XIE ⁴ ; Hai-Bo SONG ² ; Ming-Jun ZHU ⁵ ; Rui GAO ⁶ ; Zhong WANG ⁴ ; Wen-Ke ZHENG ¹ ; Xue-Lin LI ⁵ ; Meng JIANG ⁷ ; Yu-Hong HUANG ⁸ ; Fang LU ⁶ ; Li-Yun HE ⁴ ; Wei-Xiong LIAN ⁹ ; Zhong-Qi YANG ¹⁰ ; Wei-An YUAN ¹¹ ; Si-Yuan HU ¹² ; Bao-He WANG ⁸ ; Wei-Liang WANG ⁶ ; De-Quan REN ¹³ ; Bo-Li ZHANG ¹ ; null ; null
Author Information

1. Institute of Chinese medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
2. Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China.
3. Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
4. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
5. The First Affiliated Hospital of Henan Chinese Medicine College, Zhengzhou 450008, China.
6. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.
7. Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing 210029, China.
8. The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300153, China.
9. Guangdong Hospital of Traditional Chinese Medicine, Guangzhou 510120, China.
10. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
11. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
12. The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
13. The Chinese Medical Injection Cooperation, Tianjin 300193, China.
Publication Type:Journal Article
Keywords: Chinese medical injection; centralized monitoring; safety evaluation
From: China Journal of Chinese Materia Medica 2017;42(1):6-9
CountryChina
Language:Chinese
Abstract: Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.