2、请申请单位负责联系安排现场核查人员的往返交通问题。
2. Arrange the round trip transportation of the inspectors.

ruojun: Applicant is responsible for arranging the round trip transportation for the on-site inspectors.

3、现场核查及抽样的具体内容和程序要求请见国家食品药品监督管理局发布的《药品注册现场核查及抽样程序与要求（试行）》、上海市食品药品监督管理局发布的《药品注册现场核查及抽样须知》（可分别在国家食品药品监督管理局网站http://www.sfda.gov.cn法规文件栏和上海市食品药品监督管理局网站http://www.shfda.gov.cn公告通知栏下载）和国食药监注［2006］265号文。
3. The detailed contents 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 by SFDA, and 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.

ruojun: Drug Registration (Trial) tentative??
The first two can be downloaded =These documents can be downloaded....

4、药品研制所涉及的原始记录（包括原辅料检验、处方工艺研究、质量研究、稳定性研究、申报样品试制和检验、药理毒理研究等方面）应按《药品研究实验记录暂行规定》（国药管安［2000］1号）要求归档，参照附表7项目要求，须装订成册（可以线装、胶装、订书钉装等固定，不得采用活页装订或活页夹形式），列出内目录，并有连续页码编号。各试验项目尽可能合并装订。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。
4. File the original records- records of tests of APIs and excipients, formula and process research, quality research, stability study, pilot production and tests of the samples, pharmacology and toxicology study and so on- as required by Temporary Regulations on Experimental Records of Drug Research (Decree No. [2006] 1 issued by the Drug Safety and Supervision Division of SFDA). Bind the records as required by Form 7. The records may be bound with thread, glue or staples, but not in the form of loose leaves. List the contents and number the pages. Try best to bind the records of an item together. Provide original records likewise for commissioned research and contact with relative research organizations beforehand to arrange things.

ruojun: Original records related to drug development (eg.,tests of APIs and excipients, formula and process research, quality research, stability study, pilot production and tests of the samples, pharmacology and toxicology studies, etc.) should be filed by the requirement of Temporary Regulations on Experimental Records of Drug Research (Decree No. [2006] 1 issued by the Drug Safety and Supervision Division of SFDA, see appendix 7). These records might be bound with thread, glue or staples, but not in the form of loose leaves. Contents should be listed and pages should be numbered. Try best to bind the records of an item together. For contracted or commissioned research, original records should be provided likewise. Good communications with these research institutiions should be made beforehand to make sure these requirement can be met.

1、接到现场核查通知书2日内，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）及现场核查通知1份送至上海市食品药品检验所（张江张衡路1500号）业务科受理处，并提供联系人手机号码。


Within 2 working days of receipt of the On-site Inspection Notification, the applicant shall submit a set of application dossier (including one application form and one photocopy of the acceptance letter) together with the On-site Inspection Notification to the Acceptance Office of the Business Department of SIFDC at 1500 Zhangheng Road, Zhangjiang Hi-tech Park. The mobile phone number of the contact person should also be submitted.

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 ???

3、现场核查及抽样的具体内容和程序要求请见国家食品药品监督管理局发布的《药品注册现场核查及抽样程序与要求（试行）》、上海市食品药品监督管理局发布的《药品注册现场核查及抽样须知》（可分别在国家食品药品监督管理局网站http://www.sfda.gov.cn法规文件栏和上海市食品药品监督管理局网站http://www.shfda.gov.cn公告通知栏下载）和国食药监注［2006］265号文。

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.

谢谢两位！现在没时间细看，晚上再好好看看。

嗯，请教一下institution和organization的区别？药检所的英文名里用的是institution。

其实意思差不多，istitutions偏重研究和开发，机构的意思，而organization是各类组织的总称

嗯，把notice letter改成notification了。另外把语序调整了一下。谢了。不过我看FDA的网站上也有“notice letter”这个用法。请教一下它和notification的区别?notice letter指具体的文件或公文，notification通知的总称，可以是各种形式的信息传递，重点是结果。

Procedures and Requirements of On-site Inspection and Sampling for Drug Registration (Trial) issued 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.

前面的帖子里我忘了加斜体了。其实它的结构是a, b and c，您加的那个“and”可以不要的。

tentative我觉得是可以的。之所以用trial是因为以前有个英文版的药品注册管理办法（试行）用的是trial。不过那个版本估计不是药学专业的人翻译的，像“说明书”之类的专业术语都翻译得不规范。我这次也没多想，顺手就写上去了。谢谢提醒。

的确，委托研究可以用contracted research。合同研究组织就是Contract Research Organization （CRO)。