新药证书

待SR项目资金到位并顺利通过Ⅲ期临床试验后的，SR即可获得国家药监局新药证书，此时将面临最终的考验&上市。

When funds are available and clinical trials part III is past , " SR " can get new drug certificate from the State Food and Drug Administration Bureau , and then it will face the ultimate test-listing .

未获批准的，《新药证书》原件予以退还。

Otherwise the original copy of the new drug certificate shall be sent back .

至今该中心研发的产品共获国家新药证书18个。

As yet , this institution has got18 national new drug certificates .

转让方仅获得《新药证书》的，对照药品的选择应当按照《药品注册管理办法》的规定及有关技术指导原则执行。

In case the transferor did not obtain a drug approval number , the reference drug shall be selected in accordance with the Drug Registration Regulation and relevant technical guidelines .

该论文制定的质量标准于2009年3月获得国家食品药品监督管理局正式批准，同时，该项目获得国家食品药品监督管理局颁发的新药证书和生产批准文号。

The Quality Standards in this thesis have officially been approved by SFDA in March 2009 ; at the same time this project was granted the New Drug Certificate and Manufacturing Approve Number issued by SFDA .

2005年5月25日，经国家食品药品监督管理局（SFDA）批准，丹参多酚酸盐及其注射用丹参多酚酸盐的新药注册申请获得了新药证书和生产批文。

On May 25 , 2005 , a New Drug Application ( NDA ) of depsides salts from Salvia miltiorrhiza and its preparation for the treatment of coronary artery disease had received official approval from State Food and Drug Administration ( SFDA ) .

完成临床试验并通过审批的新药，由国务院药品监督管理部门批准，发给新药证书。

When a new drug has gone through clinical trials and passed the reviewing , a new drug certificate shall be issued upon approval by the drug regulatory agency of the state council .

新药技术转让注册申请获得批准的，应当在《新药证书》原件上标注已批准技术转让的相关信息后予以返还；

In case the new drug technology transfer is approved , the original copy of the new drug certificate shall be returned with added information of the transfer .