关键词: font-size:medium, ">药物警戒；信息机制；数据

Abstract: The Pharmacovigilance System were proposed in the newly revised Drug Administration Law. It would conducive to achieve the data Value-adding and expand the real world evidence (RWE) scenarios by establishing and improving of pharmacovigilance information mechanism. Based on the analysis of pharmacovigilance practice experience， legal policies， and informatization status in domestic and foreign， this paper proposed the three-dimensional data structure of the classification & hierarchical monitoring， organizational structure monitoring， and RWE of pharmacovigilance system information mechanisms. And the distributed ledger information framework of Pharmacovigilance System would being built by the combineing model with adverse drug reaction (ADR) data reporting， such as individual case safety report (ICSR) and periodic safety update reports (PSUR). And this paper summarized the construction road of pharmacovigilance information mechanism including the ADR high-quality development， classified and hierarched management， qualified person for pharmacovigilance (QPPV) and the professional associations communicating.Through analysis， evaluation， and feedback between the integration of RWE and the pharmacovigilance knowledge system， the value-adding and application of pharmacovigilance data are realized.
    

Key words: font-size:medium, ">Pharmacovigilance； Information mechanism； Data