拟建我国罕用药政策制度的探讨与建议  

Orphan Drugs System Policy to be Established in China

作　　者：曾智[1,2] 杨悦[1] 令狐昌黎[1] 汤涵[1] 

机构地区：[1]沈阳药科大学工商管理学院,沈阳市110016 [2]南宁市食品药品检验所,南宁市530022

出　　处：《中国药房》2009年第10期737-740,共4页China Pharmacy

摘　　要：目的:为我国罕用药政策制度的建立提出建议。方法:概述我国罕用药政策制度的发展现状,通过文献检索,分析并对比目前国外罕用药制度实施情况。结果与结论:我国亟需建立罕用药政策制度,且应从我国卫生经济水平和人口结构出发,从罕见病定义界定、罕用药身份获得条件、罕用药价格管理和开发基金资助及罕用药注册审批等方面建立符合本国国情的罕用药政策制度。OBJECTIVE： To put forward suggestions on the establishment of the policy of orphan drugs system in China. METHODS： The status quo of the development of the policy of orphan drugs system in China was overviewed, and by reviewing pertinent literature, the operation of the current orphan drugs system in China vs. abroad was analyzed comparatively. RESULTS ＆ CONCLUSION： It is urgent to establish the policy of orphan drugs system tailored to China＇s national condition by taking fully consideration of the factors of health economic level and population structure, the definition and division of rare diseases, the conditions to acquire orphan drugs, the management on drug price, financial support, registration and approval etc.

关 键 词：罕用药政策制度 我国 国外 建议 

分 类 号：R95[医药卫生—药学]