日本药品上市后监测与评价制度研究  

Post-marketing Monitoring and Evaluation System in Japan

作　　者：孟康康 孙楠 董铎 MENG Kangkang;SUN Nan;DONG Duo(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100022,China;Astellas Pharmaceutical(China)Co.,Ltd.,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100022 [2]安斯泰来制药(中国)有限公司,北京100022

出　　处：《中国药物警戒》2021年第10期944-948,共5页Chinese Journal of Pharmacovigilance

基　　金：重大新药创制国家科技重大专项2017年度(2017ZX09101001-001-003)。

摘　　要：目的为我国建立和完善药品上市后评价制度提供参考。方法通过查阅日本法律法规文献资料,研究构成日本上市后监测体系的重要元素。结果在药物警戒质量管理规范(good vigilance practice, GVP)和上市后研究质量管理规范(good post-marketing study practice, GPSP)两大法规的指导下,日本既完成了老药的再评价,又通过再审查对新药上市进行严格把关;通过药品上市后调查制度和药品风险管理计划(Risk Management plan, RMP),完善了药品全生命周期的管理。与日本药物上市后监测与评价制度相比,我国药品上市前后的组织机构有效衔接待加强,上市后评价的法律框架不够健全,药品监测模式有待创新。结论建议通过职能调整或建立有效沟通机制,完善我国药品上市前后评价技术支撑机构;加强完善立法,建立我国药品上市后评价体系;进一步探索老药再评价模式,创新药品评价方法。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 postlisting 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.

关 键 词：日本 上市后监测 再审查 再评价 

分 类 号：R95[医药卫生—药学]