【摘要】 采用文献分析法,从制度实施对象、实施方式和实施结果的角度介绍并分析日本新药再审查制度。日本厚生劳动省在批准新药时针对不同类型的新有效成分、剂量、给药途径或适应证药品指定不同的再审查期,再审查期内上市许可持有人须履行开展上市后调查等义务,再审查期结束后的3个月内提交再审查申请,厚生劳动省重新评估该药品的安全性和有效性。提炼出新药再审查制度每个环节的特点,提出完善我国新药上市后监测体系的启示。建议扩展新药监测范围;丰富再注册申请资料的检查方式;解决新药监测期后与药品再注册的关联问题。更多还原

【Abstract】 To provide enlightenments for monitoring post-marketing new drugs in China. Through literature analysis,new drug re-examination system in Japan was introduced and analyzed from the perspective of system implementation objects,implementation methods and implementation results. The Japanese Ministry of Health,Labor and Welfare assigns specific reexamination periods for different types of new active ingredients,dosages,routes of administration and indications when approving new drugs. During the re-examination period,marketing authorization holders must fulfill their obligations to conduct postmarketing investigations. The application for re-examination is submitted within 3 months after the end of the re-examination period,and the Ministry of Health,Labour and Welfare re-evaluates the safety and effectiveness of the new drugs. After elaborating the characteristics of each link of the new drug re-examination periods,it puts forward some enlightenments perfecting the new drug monitoring system in China. It is recommended to expand the monitoring scope of new drugs,developing more inspection methods of re-registration application materials,and solve the problem of association with drug re-registration after the new drug monitoring period.更多还原