负责审核和确认产品说明书，在规定时限内提交临床试验和新药注册申请；
Verify product description; Submit data of clinical trials and new drug registry application.
第二十五条申请新药注册，应当进行临床试验或者生物等效性试验。
Article 25 for the application for registration of new drugs, clinical trial or bioequivalence trial shall be conducted.
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.
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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