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。
To obtain orphan drug designation, drugs must be for the treatment, prevention or diagnosis of a rare disease or condition.
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。
Orphan drugs are either drug or biologic products used to treat diseases or conditions affecting fewer than 200,000 people in the United States.
Simes说，“我们的目的是利用获得指定的孤儿药物权带来的益处，继续GVAX的研发。”
It is our intention to find ways to continue the development of our GVAX Pancreas Vaccine using the benefits conferred by gaining Orphan Drug designation.
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。
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.
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.
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。
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.
研讨会期间，与会者将提出一个具体的孤儿药物按照FDA的孤儿药物审批过程进行研讨，并将其申请提交给FDA作为研讨会的总结。
During the workshop, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop.
研讨会期间，与会者将提出一个具体的孤儿药物按照FDA的孤儿药物审批过程进行研讨，并将其申请提交给FDA作为研讨会的总结。
During the workshop, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop.
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