新药申请

如适用，在新药申请中，交叉验证研究数据的信息。

In NDA submissions , information about cross-validation study data , if applicable .

在此次撤市之后，麦罗塔将来在美国的任何一种使用都将需要向FDA提交一项研究性新药申请。

Following the withdrawal , any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA .

以电子格式递交申请：新药申请。

Regulatory Submissions in Electronic Format ; New Drug Applications .

吴浈说，新的管理办法也旨在通过对新药申请进行“特殊审批”，鼓励中国的医药行业进行创新。目前这一领域还是以仿制药占压倒性多数。

Wu said that new regulations also aim to encourage innovation in China 's pharmaceutical sector currently dominated by generics by prioritising new drug applications .

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 ) .

这些产品不必需要新药上市申请。

These products do not require an NDA .

药品注册分为新药注册申请、补充申请、药品再注册申请和进口药品申请。

Drug registration is classified into new drug application , supplementary application , license renew application , and import drug application .

如果制药公司希望标记OTC但没有达到专著要求的，均可以提交新药上市的申请和获得注册新药的许可。

Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application .

新药临床研究申请须每年进行更新。内容包括这一年中有关该药物的研究结果，以及下一年度的临床研究计划。

The update contains what was learned about the compound during the year and the clinical plan for the following year .

但新药的上市申请不仅程序繁琐、资金需求巨大，而且资金一旦投入即成为沉没成本。

But the new drug application for listing does not only have cumbersome procedure and demands for huge funds , but also takes the high risk .

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 .

新药未经批准：此产品是新药，没有新药申请。

UNAPPROVED : The article appears to be a new drug without an approved new drug application .