Research on Knowledge System of Pharmacovigilance System

The pharmacovigilance system were proposed in the newly revised Drug Administration Law. The combing and designing of the pharmacovigilance knowledge system is conducive to transform and upgrade adverse drug reaction(ADR) monitoring methods, and improve the pharmacovigilance application level of the real-world evidence. Based on the analysis of the practical experience and the logical relationship between the related supervision systems, this study puts forward the technical scientific knowledge framework of the pharmacovigilance sub-species, sub-sectors and sub-channels. The pharmacovigilance knowledge system highlights the coexisting health service characteristics between traditional Chinese medicine and modern medicine, and adapts the information requirements of the information age. The application scenario and design path of pharmacovigilance knowledge system includes several fields, such as the ADR monitoring approach transforming, pharmacovigilance information mechanism constructing, social co-management participating, and the professional association decision supporting, et al.