Orphan drugs are either drug or biologic products used to treat diseases or conditions affecting fewer than 200,000 people in the United States.
孤儿药物包括药物或者生物制品，用于治疗疾病，并且在美国发病人数少于20万人。
It is recommended to perfect orphan drugs medical insurance access standard, introduce risk-sharing mechanism and standardize the use of orphan drugs and reimbursement in China.
建议完善我国罕用药医保遴选标准，引入风险共担机制及规范罕用药的使用和报销。
The European orphan diseases market grapples with numerous challenges. Of these, the most serious are the lack of awareness, poor diagnosis and limited accessibility of orphan drugs.
欧洲孤儿疾病市场存在许多问题。其中，最严重的是缺乏认识，不良的诊断和有限利用孤儿药物。
EU healthcare ministers should encourage frequent discussions with patients, patient support groups and industry representatives to ensure a transparent and rapid approval process for orphan drugs.
欧盟卫生部长会议鼓励要经常性的与患者，患者支持团体和业界代表进行沟通，以确保透明和快速审批程序孤儿药物。
To obtain orphan drug designation, drugs must be for the treatment, prevention or diagnosis of a rare disease or condition.
孤儿药物审批流程需要该药物可以用于治疗、预防或者诊断罕见疾病。
They conclude that single patient trials can be a logical approach to identifying potentially beneficial drugs, especially in the case of rare or orphan diseases.
他们认为通过对单个病人的试验能够有逻辑性的辨识药物的潜在益处，尤其在稀有罕见病例中。
Orphan drug designation is available for drugs already approved for another disease or condition or for experimental drugs that have not been previously approved.
已经被批准用于其它疾病治疗的药物或者是尚处于试验阶段未被批准的药物都可以通过孤儿药物申报程序进行。
Orphan drug designation is available for drugs already approved for another disease or condition or for experimental drugs that have not been previously approved.
已经被批准用于其它疾病治疗的药物或者是尚处于试验阶段未被批准的药物都可以通过孤儿药物申报程序进行。
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