Abstract: Periodic safety update reports addressing the worldwide safety experience of medicinal products must be provided to regulatory authorities at defined time intervals after products are marketed. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH) provides guidelines for the Periodic Safety Update Report((PSUR), ICH E2C(R1) Guideline) and the more recent Periodic Benefit-Risk Evaluation Report((PBRER), ICH E2C(R2) Guideline). The PBRER is an evolution of the PSUR, enabling a shift from the more traditional post-approval pharmacovigilance periodic summary report to a modern periodic summary report presenting the current benefit-risk assessment of the approved indications for a product based on cumulative efficacy and safety information. This paper summarizes key differences between the ICH E2C PSUR and PBRER Guidelines, describes the initial experience and challenges encountered by a multinational pharmaceutical company in effecting the transition from PSUR to PBRER format and content, and discusses the potential for implementation of the PBRER in China in the context of China's evolving pharmacovigilance system.

Key words: international conference on harmonization(ICH), periodic safety update report, pharmacovigilance, postmarketing product surveillance