我国仿制药质量和疗效一致性评价后应关注的几个问题  

Refocus on some issues after consistent assessment of generic drugs in China

作　　者：陈志东[1] 张毅[1] 张勤 CHEN Zhidong;ZHANG Yi;ZHANG Qin(Department of Pharmacy, the 6th People's Hospital, Shanghai Jiao Tong University, Shanghai 200233,China;Department of Medical Ultrasound, Dachang Community Health Service Center of Baoshan District, Shanghai 200442,China)

机构地区：[1]上海交通大学附属第六人民医院药剂科,上海200233 [2]上海市宝山区大场社区卫生服务中心超声医学科,上海200442

出　　处：《上海医药》2019年第17期56-59,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：在我国,通过质量和疗效一致性评价的仿制药(简称为"过评仿制药")已用于临床。应关注这些过评仿制药的疗效不等、药品不良品、不良反应和不合格品等问题。Many generic drugs passed consistent assessment have been clinically used in China. Some issues should be refocused on, such as therapeutic inequivalence, medical product defects, adverse drug reaction and unqualified drugs.

关 键 词：仿制药质量和疗效一致性评价 疗效不等 药品不良品 不良反应 不合格品 

分 类 号：R95[医药卫生—药学]