Abstract: The article introduced the basic principles of ICH Periodic Safety Update Reports (PSUR). The article suggested that PSUR should be promoted step by step. When the data lock point in China couldn't be synchronized with the IBD, Line-listings and Summary Tabulations, Summary Bridging Reports and Addendum Reports should be adopted depending on the circumstances. The Marketing Authorization Holder(MAH) should put emphasis on finding safety risks through PSUR, and provide clues for further investigation and risk management.

Key words: ICH, PSUR, implication