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我国仿制药一致性评价品种探析 预览 被引量:3

Analysis of the varieties of generics for quality consistency evaluation in China
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摘要 仿制药一致性评价作为提升仿制药质量重要举措,对促进医药产业升级、推进国家供给侧改革、提高公众健康福利有着重要意义。本文通过分析我国和日本评价品种范围及分阶段评价情况,并结合我国一致性评价实际推进情况,着重剖析我国一致性评价初期面临的品种问题,在此基础上,为我国一致性评价品种相关政策的完善提供建议。 Quality consistency evaluation of generics is an important initiative to improve drug quality in China and also plays a significant role in promoting the upgrading of the pharmaceutical industry, the national supply-side structural reform and the public health and welfare. The variety problems which will be faced in the initial stage of generics quality consistency evaluation were focused on by analysis of the variety scope and the phased evaluation status in China and Japan based on the actual advancement of consistency evaluation so as to to provide academic reference for perfecting policies related to generics quality consistency evaluation.
作者 丁锦希 刘莹芳 郑翠微 姚雪芳 吴逸飞 DING Jinxi, LIU Yingfang, ZHENG Cuiwei, YAO Xuefang, WU Yifei (School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China)
出处 《上海医药》 CAS 2017年第7期54-59,共6页 Shanghai Medical & Pharmaceutical Journal
关键词 仿制药一致性评价 评价品种 品种分类 分阶段评价 generics quality consistency evaluation evaluation object drug classification phased evaluation
作者简介 丁锦希,教授,博士生导师。研究方向:药品市场准入政策。E-mail:jinxi_ding@163.com
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