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Drug re-evaluation system has been developed in some developed countries for many years. In these countries, unique and mature drug re-evaluation systems have been established to make up for the insufficiency of pre-market research and review and further improve the safety and effectiveness of drugs. The importance of drug re-evaluation has been repeatedly verified in the practice of developed countries. China is establishing a pharmacovigilance system and should take advantage of the situation to establish a drug re-evaluation system adapted to China's national conditions, maintain focus on the safety of drugs throughout the life cycle, and ensure the medication safety of Chinese people. The post-marketing re-evaluation system in Japan has been developed for more than 40 years, and it is full of reference. This paper reviews the historical origin of Japan's post-marketing re-evaluation system, systematically analyzes Japan's post-marketing re-evaluation system from the aspects of object and period, change of laws and regulations, responsible subjects, and implementation procedures and so on. In the last part, practical suggestions are put forward for the construction of China's drug re-evaluation system.

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药品再评价制度已经在部分发达国家发展多年，在这些国家建起了各具特色、成熟的药品再评价制度体系，弥补了药品上市前研究和审查的不足，为药品进一步的安全性、有效性和经济性提供了可靠保障。药品再评价的重要性在发达国家的实践中被反复验证，我国应随着药物警戒制度的推行，顺势建立起适应我国国情的药品再评价制度，持续关注药品上市后安全，保障我国人民的用药安全。日本上市后再审查制度已发展40余年，具有借鉴意义。本文梳理了日本上市后再审查制度的历史渊源，从对象及期限、法规更迭、责任主体、实施程序等方面系统地剖析了日本新药上市后再审查制度，最终对我国药品再评价制度的构建提出切实建议。

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薛雨桐，女，硕士研究生，主要从事国际国内药品上市后政策与法规研究。E-mail: xytmrzy@163.com。

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薛雨桐，女，硕士研究生，主要从事国际国内药品上市后政策与法规研究。E-mail: xytmrzy@163.com。

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