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各国对罕见病治疗药物的研发均给予积极鼓励的政策,我国近年来也出台一系列政策鼓励罕见病用药的研发,目前有大量的罕见病用药在我国申请进行临床试验或上市申请,本文就罕见病用药注册申请过程中临床审评的基本考虑进行了总结,以期为罕见病药物研发提供一些参考.“,”Many governments have actively encouraged the development of drug for rare diseases.In recent years, a series of policies has been pub-lished to encourage the research of rare diseases in china , and there are a large number of orphan drugs to apply for clinical trials or approval appli-cations now.This article summarizes the basic questions of clinical re-view in application of drugs for rare diseases , which will provide some references for the research of drugs for rare diseases .