| Autor: |
Fu CK; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China., Liu H; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China., Wang LX; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China., Zou YH; Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China., Li MQ; the Third Affiliated Hospital of Changchun University of Chinese Medicine Changchun 130117, China., Lin YM; Yunnan Provincial Hospital of Traditional Chinese Medicine Kunming 650021, China., Sun WH; General Hospital of Ningxia Medical University Yinchuan 750004, China., Wei X; Wangjing Hospital, China Academy of Chinese Medical Sciences Beijing 100102, China., Hu YE; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China., Xie YM; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China., Li YY; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China. |
| Abstrakt: |
In 2019, the newly revised Drug Administration Law of the People's Republic of China was issued and implemented,clearly proposing that China should establish a pharmacovigilance system. As a new traditional Chinese medicine(TCM) dosage form created in China, TCM injections have been widely used in clinic, and its pharmacovigilance has attracted much attention. In response to this situation, the project team convened a group of clinical, pharmaceutical and evidence-based medicine experts from all over the country to form an expert group, which formulated the Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections in strict accordance with the requirements of the group standards of the Chinese Association of Chinese Medicine.From the perspective of clinical application and considering the key elements of pharmacovigilance for clinical application of TCM injections, the guidelines put forward suggestions on the decision making of pharmacovigilance for clinical application of TCM injections from four key links, namely the monitoring and reporting, signal recognition, risk assessment and risk control, according to China's pharmacovigilance regulations and learning from foreign pharmacovigilance guidelines. |
