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1、.制药行业术语和英文简称名词解释NDA : New Drug Application /新药生产上市申请INDA : Investigational New Drug Application/药品临床试验申报ANDA : Abbreviated New Drug Application/仿制药及改剂型申请提出申请快速通道资格认定（Request for Fast Track Designation)Accelerated Approval（加速审批）: These regulations allowed drugs for serious conditions that filled an u
2、nmet medical need to be approved based on a surrogate endpoint.Breakthrough Therapy Designations（突破性疗法资格认定）: A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.Fast Track Designation（快速通道资格认定）: Fast track is a proce
3、ss designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.Priority Review（优先审核）: A Priority Review designation means FDAs goal is to take action on an application within 6 months.Orphan Drug Act（罕见疾病药物法案）:也叫孤儿药注册1类和2类新药要进行新
4、药临床试验申请（INDA）；3类和4类要做验证性临床。完成临床试验后进行新药生产上市申请（NDA）。仿制及改剂型申请（ANDA）为5类和6类的生物等效试验申请和生产上市申请。至于验证性试验其实对应的是探索性试验，这两个概念指药物开发的试验，而且其概念也不是绝对化的。phase I 和II基本属于探索性试验阶段，Phase III 和IV基本属于验证性试验阶段。所谓验证性试验，是对已经获得的初步的治疗作用进行确证的试验。一般包括注册分类3的药物及创新药物的III期临床实验。在创新性药物的临床试验中，期临床试验正是验证性的研究，是对I 和期临床试验探索出的初步的治疗作用进行验证。此外 期临床试验还有一个重要的目的是对药物的安全性的研究，因此它需要有更大的样本量。.;