美国孤儿药法案30年历程与我国新药创新制度体系完善
Improving Chinese innovation system of new drug according to 30-year history of U.S.Orphan Drug Act
易八贤 1王广平 2姬海红 3吴晓明4
作者信息
- 1. 中国药科大学,南京210009;中国医药工业研究总院,上海200040
- 2. 上海市食品药品安全研究中心,上海200233
- 3. 成都大学,成都610106
- 4. 中国药科大学,南京210009
- 折叠
摘要
孤儿药研发和生产具有临床试验成本高、目标市场小、获利能力差的特征.美国孤儿药法案(ODA) 30年历程形成的孤儿药制度,带动了美国生物医药产业快速增长,成为显现药品创新制度绩效的国际软标准,许多国家和地区效仿并建立了孤儿药制度体系.基于美国与部分国家(地区)孤儿药政策、新药创新制度的对比分析,本文提出了基于孤儿药政策的我国新药创制体系的构建路径,例如罕见病孤儿药的区域目录、孤儿药创新激励政策、各部门政策相协调等.
Abstract
Characteristics of the orphan drug R&D and manufacture includes the high costs of clinical trials,small target market,and poor profitability.Orphan drug system led to the rapid growth of U.S.biomedical industry by the 30-year history of Orphan Drug Act (ODA).Orphan drug system had become the international standard to show performance of the soft drug innovation system.Many countries and regions have followed this and set up orphan drug system.The paper proposed to build the Chinese new drug innovation system relating to the orphan drug policies,which is based on several comparison analyses of the orphan drug policy,innovation performance evaluation,and the new drug innovation system between United States and other countries (regions),such as the regional catalog,innovation incentives,governmental policy coordination,and so on.
关键词
美国/孤儿药/制度标准/新药/创新制度Key words
United States/orphan drug/system standard/new drug/innovation system引用本文复制引用
出版年
2014
NETL
NSTL
维普
万方数据