中华医院管理杂志
中華醫院管理雜誌
중화의원관리잡지
CHINESE JOURNAL OF HOSPITAL ADMINISTRATION
2010年
8期
601-604
,共4页
罕用药%罕见病%罕用药制度%药事管理
罕用藥%罕見病%罕用藥製度%藥事管理
한용약%한견병%한용약제도%약사관리
Orphan drugs%Rare disease%Orphan drug management system
实施罕用药制度可以显著提高罕见病患者治疗水平和生存质量,促进医药科技发展进步.作者参考国外的罕用药法规,汇集各国罕用药管理经验,包括罕用药认定、研制开发的扶持措施、市场保护、临床使用管理等,结合中国国情,讨论建立实施罕用药制度的方法策略和现实意义.
實施罕用藥製度可以顯著提高罕見病患者治療水平和生存質量,促進醫藥科技髮展進步.作者參攷國外的罕用藥法規,彙集各國罕用藥管理經驗,包括罕用藥認定、研製開髮的扶持措施、市場保護、臨床使用管理等,結閤中國國情,討論建立實施罕用藥製度的方法策略和現實意義.
실시한용약제도가이현저제고한견병환자치료수평화생존질량,촉진의약과기발전진보.작자삼고국외적한용약법규,회집각국한용약관리경험,포괄한용약인정、연제개발적부지조시、시장보호、림상사용관리등,결합중국국정,토론건립실시한용약제도적방법책략화현실의의.
The orphan drug management system can significantly improve the quality of care and that of life of patients suffering from rare diseases, and accelerate the progress of medicinal science. With
experiences of practicing the orphan drug management system in developed countries and regions,including certification of orphan drugs, supports for developing orphan drugs, market protection and clinic application management. Based on such studies, the authors discussed the feasibility and methodology of establishing an orphan drug management system in China, along with the significance of such a system.
