Objective To explore a pharmacovigilance system of traditional Chinese medicine(TCM)that is compatible with the characteristics of traditional Chinese medicine in order to provide reference for safe use of TCM.Methods The origin and development of pharmacovigilance of TCM were reviewed,the undertakings by regulatory agencies in the field of pharmacovigilance of TCM in recent years were summarized,and the determinants of pharmacovigilance of TCM were discussed.Results Since the establishment of the pharmacovigilance system,the laws and regulations on pharmacovigilance of TCM have been improved,and pharmacovigilance of TCM has proved fruitful enough to provide reference for safe use of TCM.Conclusion Pharmacovigilance of TCM should always be guided by the TCM theories of"holistic view"and"syndrome differentiation and treatment".Effort should be made to establish evaluation methods in line with the characteristics of modern TCM so as to facilitate the safe and effective use of traditional Chinese medicine in clinical practice and promote the high-quality development of pharmacovigilance of TCM.
关键词
中药/药物警戒/风险防控/药品不良反应/用药安全/说明书修订
Key words
Traditional Chinese Medicine/pharmacovigilance/risk prevention and control/adverse drug reaction/drug use safety/revision of instructions
维普
万方数据