Abstract: Objective To provide a reference for the establishment of post-marketing evaluation system in China by summarizing the experience of post-marketing evaluation in Japan. Methods The similarities and differences between drug post-marketing evaluation in China and in Japan were compared by academic exchanges and the literature. Results Japanese post-marketing evaluation is mainly composed of two systems, which were reevaluation and reexamination. The reevaluation system is for solving the "old medicine" defects, and the reexamination system is for promoting the "new drug" monitoring and research. These systems effectively cover all of Japanese medicines. Conclusion Japanese post-marketing evaluation system is very unique, suitable for reference to the construction of Chinese drug post-marketing evaluation system.

Key words: Japan, drug, post-marketing, evaluation, reevaluation, reexamination