当前位置:
首页
网刊
影响我国化学药品仿制药质量因素的问卷调查分析
影响我国化学药品仿制药质量因素的问卷调查分析
陈 震1,3,杨建红2,3,张彦彦3,韩 鹏3

1 郑州大学药学院,郑州 450001;2 国家食品药品监督管理总局药品审评中心,北京 100038;3 沈阳药科大学亦弘商学院,北京 100027
Investigation and analysis on the factors affecting the quality of chemical generic drugs in China
(1 School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou 450001, China; 2 Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China; 3 Yeehong Business School, Shenyang Pharmaceutical University, Beijing 100027, China)

摘要参考文献相关文章

起始页:1477

摘要:[摘要] 针对影响我国化学药品仿制药质量的因素进行了问卷调查,大多数参与调查人员肯定了过去10年里我国仿制药质量的进步。调查结果显示,我国仿制药的研发理念正在发生转变,国际上先进的研发理念和质量理念已逐渐被业界接受。调查结果也显示,我国在研发能力、数据完整性、注册管理和技术要求以及市场准入政策等方面尚存在一些影响仿制药质量的问题,有待进一步改进。

关键词:[关键词] 化学药品;仿制药;质量;问卷调查

通讯作者:

基金项目:

作者简介:

Abstract:[Abstract] A questionnaire survey was carried out to investigate the factors affecting the quality of chemical generic drugs in China, and most of the subjects confirmed the progress of the quality of chemical generic drugs in the past 10 years. The results showed that the R&D concept of chemical generic drugs in China has been changing, the international advanced R&D concepts and quality concepts have been gradually accepted by the industry. The results also showed that there are some issues affecting the quality of chemical generic drugs need to be further improved, with respect to the R&D capability, data integrity, registration management, technology requirements as well as market access policies.

Key words:[Key words] chemical drug;generic drug;quality;questionnaire survey

    [1] 陈震,杨建红,张彦彦,等. 影响我国化学药品仿制药质量的潜在因素分析[J]. 中国新药杂志,2017,26(12):1345-1350.
    [2] 国家食品药品监管管理总局. 药品注册管理办法(局令第28号)[EB/OL]. 2007[2016-11-15]. http://www.sda.gov.cn/WS01/CL0053/24529.html.
    [3] 国家食品药品监督管理总局. 化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则(试行)[EB/OL]. 2015[2016-12-28]. http://www.sda.gov.cn/WS01/CL0087/126004.html.
    [4] 国家食品药品监督管理总局. 化学药品注射剂与塑料包装材料相容性研究技术指导原则[EB/OL]. 2012[2016-12-28]. http://www.sda.gov.cn/WS01/CL1616/90946.html.
    [5] 国家食品药品监督管理总局. 关于药包材药用辅料与药品关联审评审批有关事项的公告(2016年第134号)[EB/OL]. 2016[2016-11-10]. http://www.sda.gov.cn/WS01/CL0087/162540.html.