• Yan-Ming Xie, Xing Liao, Jun-Jie Jiang, Yun-Ling Zhang, Rong Ma, Ming-Jun Zhu, Si-Yan Zhan, Jian-Ping Liu, Jian Liu, Ze-Huai Wen, Zhong-Qi Yang, Yan He, and Xue-Lin Li.
• Centre for Evidence-Based Traditional Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China.
• Zhongguo Zhong Yao Za Zhi. 2019 Jul 1; 44 (14): 2896-2901.

AbstractIn 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.

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