Abstract: By analyzing the relevant provisions of descriptions and characteristics of the PSUR system, included the background and significance of the PUSR development, the contents of the requirements and data sources, the frequency of reporting and the main responsibility. It recommend that China should improve and promote the PSUR system, as to be a complement of Chinese adverse reaction reporting system, while clarified its main reporting and improved enterprise on a regular basis to report adverse reactions and sense of responsibility.

Key words: post-market drug safety supervision, adverse reaction reports, Periodic Safety Update Report(PSUR)