法律、行政法规规定须报经有关部门审批的，应当在申请设立登记时提交批准文件。

Where approval by the relevant authorities is required by law or administrative regulations, the approval document shall also be submitted when applying for establishment registration.

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该公司拟在2011年年中完成该药物剩余的试验，并在六个月后向美国食品和药物管理局提交批准申请。

The company intends to complete additional trials of the compound by mid-2011, and to submit an application for approval to the US Food and Drug Administration about six months later.

youdao

注意：为了保持简单性，我们使用了一个单个用户提交、批准和发布变更。

Note: to keep it simple, we've used a single user to submit, approve and publish changes.

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