摘要
以美国FDA为代表的欧美发达国家均建立完善针对罕见病和孤儿药的专门监管机构和措施,而我国罕见病的防治没有得到足够重视,甚至被边缘化,我国孤儿药管理制度较欧美国家存在明显欠缺。本文通过文献研究法对比分析各国孤儿药管理制度,根据中国国情提出促进我国孤儿药政策建设的建议。为国家孤儿药政策的建设提供参考,以促进我国孤儿药管理制度的实施。
Special regulators have been established in many developed countries with the representative as FDA in the United States.Special regulative department took measures to completely manage rare diseases and orphan drugs.However,Chinese regulatory has not paid much attention to prevention and treatment of rare disease,so even been marginalized.China is obviously defective in orphan drug management.In this paper,we contrastively analyzed orphan drug management systems in several other countries by literature research method.According to Chinese national conditions,we put forward some suggestions as references for the development of orphan drug policy for promoting the implementation of orphan drug management system in China.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2013年第14期1638-1642,共5页
Chinese Journal of New Drugs
关键词
孤儿药
管理制度
政策建议
orphan drugs
regulatory system
suggestion
