摘要
在我国药品市场中仿制药占据绝大部分市场份额,然而仿制药的质量参差不齐,严重影响了广大患者的用药安全,因此,如何提升仿制药的质量在政府、学术界以及整个医药行业中一直备受关注。本文整理了国内外学者们针对仿制药一致性评价问题的研究,从我国仿制药的发展现状,仿制药一致性评价原则与方法,仿制药一致性评价对医药行业的影响,完善仿制药一致性评价体系的对策等角度细致展开,以期为开展仿制药一致性评价研究提供参考。
Generic drugs account for most of the market share in the pharmaceutical market in China. However,the quality of generic drugs is uneven,which seriously affects the safety of medication for the majority of patients. Therefore,how to improve the quality of generic drugs has attracted much attention in government,academia and the entire pharmaceutical industry. This article collates domestic and foreign scholars＇ researches on the issue of generic drug conformity assessment. From the development status of China＇ s generic drugs,principles and methods for consistency assessment of generic drugs,the impact of the conformity assessment of generic drugs on the pharmaceutical industry,and the measures to improve the conformity assessment system for generic drugs,four perspectives were developed. In order to provide reference for carrying out generic pharmaceutical consistency evaluation research.
作者
马志爽
李勇
MA Zhi-Shuang;LI Yong(School of International Pharmaceutical Business,China Pharmaceutical University,Jiangsu Nanjing 211198,China)
出处
《中国药物评价》
2018年第4期288-291,共4页
Chinese Journal of Drug Evaluation
基金
江苏省高校哲学社会科学指导项目基金(基金编号:2017SJB0052)
中国药科大学国际医药商学院力凡胶囊科研基金(基金编号:LFJJ-07)
关键词
仿制药
一致性评价
药品质量
Generic drugs
Consistency assessment
Drug quality
