Abstract: Objective To provide references for the post-marketing evaluation system in china by studying and summarizing the design and framework of the post-marketing drug evaluation system in developed countries. Methods The related literatures of post-marketing evaluation in Japan were reviewed and summarized. Results Japan has established a post-marketing drug evaluation system which is based on the adverse drug reactions and infection reporting system. The reexamination system that includes Early Post-marketing Phase Vigilance (EPPV), Period Safety Update Report (PSUR), Risk Management Plan (RMP) and drug use investigation is the main line for this post-marketing drug evaluation system. The implement of the system must be follow Good Vigilance Practice (GVP) and Good Post-marketing Study Practice (GPSP). Additionally, an Ad Hoc reevaluation system is established as a part of post-marketing drug evaluation system for the drugs out of the reexamination period. Conclusion Japan has developed a comprehensive system for drug post-marketing evaluation. The experience in the post-marketing evaluation system from Japan has a reference value for China to carry out related work.

Key words: Japan, medicine, post-marketing, evaluation