Objective:To comprehensively summarize the pharmacovigilance work of traditional Chinese medicine(TCM)in China,sort out the problems existing in the development and propose solutions,and so as to provide references for establishing a pharmacovigilance system in line with the characteristics of traditional Chinese medicine and improving the level of safe use of traditional Chinese medicine.Methods:By combing the historical development and current situation of TCM pharmacovigilance,this paper analyzed the new technologies applied in TCM pharmacovigilance in recent years,discussed the problems existing in the development of TCM pharmacovigilance,and proposed solutions from the aspects of TCM safety research,TCM quality evaluation and clinical vigilance system construction.Results and Conclusion:At present,there are still some problems in the practical work of pharmacovigilance of traditional Chinese medicine in China,such as the lack of guiding principles for post-marketing safety research of traditional Chinese medicine,the quality evaluation system and the imperfect pharmacovigilance system of traditional Chinese medicine in medical institutions.The regulatory authorities,medical institutions and conventional Chinese medicine production enterprises must work together to accelerate the introduction of guidance documents for the safety research of traditional Chinese medicine and the improvement of the pharmacovigilance system of traditional Chinese medicine in medical institutions,strengthen the research on the quality evaluation system of traditional Chinese medicine and the scientific supervision of pharmacovigilance,and implement the responsibilities of traditional Chinese medicine decoction pieces production enterprises,so as to jointly promote the construction of the pharmacovigilance system of traditional Chinese medicine.
troditional Chinese medicinepharmacovigilancehistorical evolutionadverse drug reactions monitoringdrug safetydevelopment statusregulatory science
维普
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