Abstract: Objective To provide reference for facilitating and optimizing China's periodic safety update report (PSUR) assessment according to the introduction of PSUR assessment process of European Union(EU) guideline on good pharmacovigilance practices(GVP). Methods Literature study was used to analyze the European Medicines Agency(EMA) and China Food and Drug Administration(CFDA) website information about PSUR assesment process. Results By optimizing the allocation of resources, the EU has adopted different PSUR assessment procedures for different medicinal products. This initiative aims to harmonize and strengthen the safety and benefit-risk review of medicines across the European Economic Area. Conclusion We should learn from EU processes for PSUR assessment to improve our ability to monitor drug safety．

Key words: guideline on good pharmacovigilance practices(GVP), pharmacovigilance, periodic safety update report, assessment