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 orphandrugs.
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。
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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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To obtain orphan drug designation, drugs must be for the treatment, prevention or diagnosis of a rare disease or condition.