原文由 poorlittle 发表:
It is a challenge to translate the word 受理. 受理 seems a short form of a legal term 受理上訴的(appellate)? But here means 我会应你的要求去处理, 受=应你的要求, 理=处理. 重心在”处理”, Is there any word better than “Acceptance”?
受理处 --> Executive Office ???
原文由 poorlittle 发表:
3. The details and procedures of the on-site inspection and sampling can be found in Procedures and Requirements of On-site Inspection and Sampling for Drug Registration (Trial) issued (or promulgated) by SFDA, Notice of On-site Inspection and Sampling for Drug Registration issued by SHFDA and the Decree No. [2006] 265 issued by the Drug Registration Division of SFDA. The first two can be downloaded at the Regulations Column of SFDA website http://www.sfda.gov.cn and at the Announcements Column of SHFDA website http://www.shfda.gov.cn.
原文由 happyjyl 发表:
Hard copy: 硬拷贝(由电子计算机,缩微胶卷等复制的无需专门设备即可阅读的打印件)。与之相反的是soft copy:软拷贝(显示在屏幕上的内容)。
原文由 happyjyl 发表:
所以药检所和药监局的受理处都侧重于“受”,而不是“理”。
原文由 happyjyl 发表:
6、药品研制过程所涉及的各试验项目研究人员、样品试制、检验、质量保证负责人、药品注册负责人、机构负责人、相关的原材料、样品、各类原始记录、档案资料、票证凭据等的保管人员、财务人员在现场核查过程中应在岗,并按照现场核查人员的要求配合核查工作。所有相关人员需至检查现场亲笔签名。
6. 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, and finance staff should be on the inspection site and support the inspectors. All relative staff should be on site and sign in person.
原文由 poorlittle 发表:
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
原文由 poorlittle 发表:
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.
原文由 happyjyl 发表:
7、被核查单位负责人应熟悉所报品种的研制情况,并应向现场核查人员汇报产品研制的基本经过、研制过程中需要说明的问题。对于实际情况与有关要求不完全相符,以及尚未按规定递交变更申请等问题,应提供加盖公章的书面汇报,并在药品研制情况汇总表相应位置备注栏作出标注。
7. The heads of the inspected organizations should be familiar with the research of the applied product and present to inspectors the process and questions subject to explanation. Present stamped written reports for problems such as failing to agree with relative requirements or to submit application for change as required and remarks in the Remarks Column of Drug Research Summary Form.