日本蓝皮书的介绍及启示-中国药事.PDF

中国药事 2018年4月 第32卷 第4期 451 日本蓝皮书的介绍及启示 郭志鑫，南楠，乔利涛，许鸣镝 （中国食品药品检定研究院，北京 100050） 摘要 目的： 介绍日本仿制药上市后质量动态信息的最新查询途径，为建立我国相关橙皮书提供借鉴。 方法：介绍日本蓝皮书的背景、结构和内容，并以熊去氧胆酸片为例，详细介绍日本蓝皮书的使用方法。 结果与结论：仿制药质量再评价工作在日本开展了近 20 年，淘汰了约 10% 的不合格药品。对于仿制药质 量再评价的跟踪和实施、市场抽验及药品质量研讨会有效保证了口服固体仿制药药品质量的一致性和有 效性，日本蓝皮书是对该项工作成果的集中系统整理，对我国开展仿制药一致性评价工作具有积极的启 示。 关键词： 日本蓝皮书；仿制药质量再评价；质量动态信息；熊去氧胆酸片 R951.3/.7 A 1002-7777(2018)04-0451-06 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.04.005 Introduction and Inspiration of Japanese Blue Paper Guo Zhixin, Nan Nan, Qiao Litao, Xu Mingdi (National Institutes for Food and Drug Control, Beijing 100050, China) Abstract Objective: To introduce the latest query route of dynamic quality information of Japanese post- market generic drugs and to provide references for the establishment of China orange paper. Methods: The background, structure and content of the Japanese blue paper were introduced. Moreover, how to use the Japanese blue paper was introduced in detail by using ursodeoxycholic acid tablet as an example. Results and Conclusion: It has been nearly 20 years since the re-evaluation of the quality of generic drugs in Japan. About 10% substandard drugs had been withdrawn from the market. As a follow-up of the re-evaluation of the quality of generic drugs, sampling test and drug quality information seminar effectively ensure the consistency and effectiveness of oral solid generic drugs. The Japanese blue paper is a centralized and systematic collection for the results of the work, and has a positive inspiration for the consistency evaluation of the generic drugs in China. Keywords ： Japanese blue paper; re-evaluation of the quality of generic drugs; dynamic quality information; ursodeoxycholic acid tablet 1998年，日本政府启动了药品质量再评价工 生产的同一种药品与原研药（在日本上市）的临 程，以厚生劳动省（MHLW）为主导、由医药品医