| 各国生物制品数据保护制度对比研究及完善我国生物制品数据保护制度的建议 |
| |
| 引用本文： | 杨建红,王晓东,陈亭,韩鹏.各国生物制品数据保护制度对比研究及完善我国生物制品数据保护制度的建议[J].现代药物与临床,2019,34(4):921-925. |
| |
| 作者姓名： | 杨建红 王晓东 陈亭 韩鹏 |
| |
| 作者单位： | 沈阳药科大学 亦弘商学院,北京,100027;辉瑞投资有限公司,北京,100000;苏州康宁杰瑞生物科技有限公司,江苏 苏州,215125 |
| |
| 摘 要： | 试验数据保护是鼓励创新、平衡创新与仿制的重要措施,各国监管机构均制定了相关管理制度。通过对美欧日韩等国家生物制品数据保护制度进行对比研究,提炼管理要素;结合我国数据保护制度的现状、设计问卷、开展调研和专家研讨;综合对比研究、调研和研讨,提出完善我国生物制品数据保护制度的建议。
|
| 关 键 词： | 生物类似药 数据保护制度 比对研究 问卷调研 建议 |
| 收稿时间： | 2019/3/7 0:00:00 |
Comparative study of the system of data protection for bio-similar drugs of different countries and recommendation on improvement for China |
| |
| YANG Jian-hong,WANG Xiao-dong,CHEN Ting and HAN Peng.Comparative study of the system of data protection for bio-similar drugs of different countries and recommendation on improvement for China[J].Drugs & Clinic,2019,34(4):921-925. |
| |
| Authors: | YANG Jian-hong WANG Xiao-dong CHEN Ting and HAN Peng |
| |
| Institution: | School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China,Pfizer Investment Co., Ltd., Beijing 100000, China,ALPHAMAB, Suzhou 215125, China and School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China |
| |
| Abstract: | Experimental data protection is an important measure to encourage innovation and balance innovation and imitation. A comparative study on the biological product data protection systems in the United States, Europe, Japan, and Korea is made to extract the management elements in this paper. The status quo of China''s data protection system, questionnaire design, research, and expert discussion are combined. Based on the comprehensive comparative study, investigation, and discussion, some suggestions to improve the data protection system of biological products in China are put forward in this paper. |
| |
| Keywords: | bio-similar drug the system of data protection comparative study questionnaire survey recommendations |
| 本文献已被 CNKI 万方数据 等数据库收录！ |
| 点击此处可从《现代药物与临床》浏览原始摘要信息 |
| 点击此处可从《现代药物与临床》下载免费的PDF全文 |
|
