Abstract: Objective To analyze the differences between periodic safety update reports for marketed drugs in China and periodic benefit-risk evaluation report in International Council for Harmonization (ICH). Methods The differences of periodic safety update reports between China and ICH is performed by comparing ICH (R1) (periodic safety update reports for marketed drugs, PSUR), ICH (R2) (periodic benefit-risk evaluation report, PBRER) and relevant laws and regulations in China. Results In terms of time requirement, the deadline for writing and submitting PSUR in China is 60 days, while the deadline for writing and submitting ICH is divided into 70 calendar days or 90 calendar days according to the characteristics of its drugs. In terms of content, China mainly collects safety-related content during the reporting period, while the ICH collects safety-related and efficacy-related content during the reporting period and accumulated content in the early stage. PBRER also includes a description of signal detection and evaluation methods. Conclusion Although there are differences between the requirements of China and ICH, China will pay more attention to the benefit-risk evaluation and the differences will gradually narrow in the future with the development of pharmacovigilance activities as well as increasing demands on marketing authorization holders.

Key words: periodic safety update report, periodic benefit-risk assessment report, differences