关键词: 日本, 上市后监测, 再审查, 再评价

Abstract: Objective To provide references for the establishment and improvement of post-marketing evaluation systems in China. Methods By referring to Japanese laws and regulations, the important elements of the post-listing monitoring system in Japan were studied. Results Under the guidance of Good Vigilance Practice (GVP) and Good Post-marketing Study Practice (GPSP), Japan has not only completed the reevaluation of old drugs, but also exercised rigorous control over the marketing of new drugs through reexamination. Through the post-marketing survey and risk management plan (RMP), the management of the whole life cycle of drugs has been improved. Compared with the Japanese drug post-marketing monitoring and evaluation system, the coordination before and after marketing in China is not effective enough, the legal framework of post-marketing evaluation is imperfect, and the drug monitoring model needs to be innovated. Conclusion It is recommended that technical support institutions of drug evaluation before and after marketing in China be improved through functional adjustment, legislation be updated, post-marketing evaluation systems of drugs be established, and drug evaluation methods be innovated.

Key words: Japan, post-marketing monitoring, reexamination, reevaluation