我当时也是想了半天，翻译这种东西最头大了。在现场核查中，药检所的受理处并不参与决策，只是把你递交的注册申请表和现场核查通知转给科室负责人，由科室负责人安排核查人员。所以我觉得还是用acceptance较好。受理处干的都是接收样品、开通关单之类跟业务有关的事项，Executive office（行政办公室）应该是专门管行政那一块的，跟具体业务没什么关系。不知道您是在香港、台湾还是澳门，你们那里有没有“形式审查”这一说？我们这里药监局的受理处就是负责形式审查的。你把申报资料交上去，受理处的人只是检查一下资料项目是否齐全、有没有公章、申请表中的地址跟营业执照是否符合之类的，具体的研究内容他们是不看的。所以药检所和药监局的受理处都侧重于“受”，而不是“理”。我想如果在政府办事效率很高的香港，是不会有“形式审查”一说的吧？

好建议。promugate：1.To make known (a decree, for example) by public declaration; announce officially. 2.To put (a law) into effect by formal public announcement.

Hard copy : generally means printed copy
Soft copy : copy in electronic form (“give me a soft copy of this report” means give me an electronic file (by email, CD, thumb drive etc.) of the report.)

Translation of copy:
(1)    份 (such as “3 copies of blank application form”)
(2)    副本 (such as “one original and 2 copies”)
副本 may be in the form of carbon copy or photocopy (或手抄本等)
But 复印本一定是副本, the corresponding English should be photocopy, not hard copy

Preliminary suggestions:

如有委托研究项目，亦应按上述要求提供原始记录，请事先与相关研究单位联系，做好协调工作。
If there is any commissioned research project involved, the original records should also be prepared in the same manner as stipulated above. Please liaise with the relevant research institute in advance.

（1）……………末页在规定处签字盖章及填写日期。
(1)………………Sign, stamp and date at the designated spaces on the last page.

（3）《药品研制情况核查报告表》原件一式5份，以及复印件1份，
(3) The original of Drug Research Inspection Report Form in quintuplicate and one photocopy. (i.e. 5+1)
(3) The original of Drug Research Inspection Report Form in quintuplicate and one set of photocopy. (i.e. 5+5)

（4）………现场核查时填写的部分（粗框）不需要填写
(4)………except the space (delineated with bold thick lines) reserved for official use
(4)………except the space (delineated with bold thick lines) reserved for the use by the inspector

（4）个别原始资料无法装订的以及其他特殊情况，应在“备注”栏注明
(4) Should there be any special matter such as some original records were not incorporated into the binded bound volume etc., elaborate it in the Remarks Column. (or just "in the Remark")

Please also consider "outsourced research"

(outsourced = contracted out)

I see. If your application is 受 , it means that 药监局 grants consent to proceed an inspection.

Then, 受理通知书 is a notice of consent to proceed the inspection requested by you.

Suggested translation for:
……请申请单位将申报资料1套（包括申请表、受理通知书复印件各1份）……

……submit a set of application dossier (including one application form and one photocopy of the Notice of Consent to Proceed the Inspection (hereafter called Notice of Consent)) together with the On-site Inspection Notification to ……

“hereafter called” is commonly used in legal document to simplify long terms

======================

After re-consideration, the above seems incorrect.

It seems that if your application is in order, 药监局受理处 will keep the materials of application (forms, records etc.) submitted by you and onward pass to 药监局XX处 to consider whether an inspection is to be proceeded. Then 受理通知书 seems an acknowledgement of receiving the application.

Suggested alternative:

The following persons should be present on site during the inspection and render assistance as directed by the inspectors:
    * Research staff;
    * Persons in charge of pilot production, test, quality assurance and registration;
    * Heads of the organizations;
    * Keepers of the APIs, samples, original records, files and credence etc.;
    * Finance staff.

All relevant staff should be on site and sign in person whenever required.

非常感谢！的确应该是photocopy。因为这里的复印件是指原件加盖公章后在复印机上复印出来的，而不是打印的，所以不应该用hard copy。

您的理解非常正确。药监局审评中心决定进行现场核查后，就会开出现场核查通知单。我们把它送到药检所业务科，由业务科转交给相应的科室负责人，由科室负责人安排人员跟药监局的人一起进行现场核查。

7. The heads of the organizations being inspected should be familiar with the research of the product under application (assessment, evaluation ?) and capable to present to (or to brief?) the inspectors the basic process and key points of the research work.

For any non-compliance to the requirements or any change without supplementary application for amendment, it shall be reported in writing with endorsement by means of official stamp, and also be indicated at the corresponding remark column of the “Drug Research Summary Form”