这将需要提出新的许可申请，包括开展新的生产验证研究，以及临床前和临床研究。
This would require a new licensing application, including conducting of new manufacturing validation studies; and pre-clinical and clinical studies.
申请已有国家标准的药品注册，一般不需要进行临床研究。
Generally, it is not necessary to conduct clinical study for the application for registration of drugs with existing state standards.
申请人对临床研究用药物的质量负有全部责任。
The applicant shall bear all the responsibilities for the quality of the drugs for clinical study use.
本研究基本完成了国家一类新药制剂学部分的临床前资料，处方已申请专利。
The preclinical study of it as lnd category new drug of China have been finished basically and the formulation has been patented.
美国临床肿瘤学协会已经向美国国家卫生研究院申请近7%的预算增长。
The American Society of Clinical Oncology has asked for a nearly 7 percent increase in the National Institutes of Health budget.
该新药申请文件包含三期临床的三大关键研究数据，所有这些都符合主要疗效终点。
The NDA file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints.
该新药申请文件包含三期临床的三大关键研究数据，所有这些都符合主要疗效终点。
The NDA file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints.
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