相关情况
RELATIVE INFORMATION

22专利情况：专利权属声明：我们声明：本申请对他人专利不构成侵权。
Patent information: patent declaration: we declare that this application does not infringe any other’s patent.

23是否涉及特殊管理药品或成分：
If the drug is subject to special administration or contains any ingredients subject to special administration：

否
No

立项批复文件号^[4]:
The number of the official approval document of the proposal:

24中药品种保护^[5]:
Drugs under application for TCM protection:

25同品种新药监测期^[6]:
Monitoring period of new drugs for products of the same drug by other enterprises:

无
None

26本次申请为：首次申请
This application is: initial application

[4]: If the drug is subject to special administration or contains any ingredients subject to special administration, the applicant should propose and get the official approval document of the proposal from SFDA before filling in this application form.

[5]: For those products under application for TCM protection, application for generic products of the same drug will be suspended from the date the protection application was accepted to the date an administration decision is made.

[6]: To ensure public health, SFDA may implement a monitoring period for the approved new drugs to monitor the safety. For new drugs under the monitoring period, SFDA shall not approve production, dosage change and importation of the drug by other enterprises.

申请人及委托研究机构
APPLICANTS AND CONTRACT RESEARCH ORGANIZATIONS

27机构1（境外制药厂商）：
The 1st organization (foreign manufacturer):

中文名称：**
Chinese name: **

英文名称：**
English name: **

法定代表人：** 职位：**
Legal representative: ** Position: **

注册地址：**
Registered address:**

国家或地区：**
Country or region: **

注册申请负责人：** 职位：**
The person responsible for registration: ** Position: **

电话：** 传真：**
Tel: ** Fax: **

电子信箱：**
E-mail: Mallikarjun.Chityala@matrixlabsindia.com

法定代表人（签名）： （加盖公章处）
Legal representative (signature): (affix with the official stamp)
年 月 日
Year month date

人用药里，potency是用来指抗生素的效价，相当于化药的assay。

在人用药里不能用effect。effect是指药物的有效性，即对疾病预防或治疗的效果，跟“规格”是有区别的。“规格”是指每剂药物中活性成分的含量。

28机构2（进口药品生产厂）：
The 2nd organization (manufacturer of the imported drug):

中文名称：××
Chinese name: ××

英文名称：××
English name: ××

法定代表人：×× 职位：××
Legal representative: ×× Position: ××

生产地址：××
Manufacturing address: ××

国家或地区：××
Country or region: ××

注册申请负责人：×× 职位：××
The person responsible for registration: ×× Position: ××

电话：×× 传真：××
Tel: ×× Fax: ××

电子信箱：××
E-mail: ××

法定代表人（签名）： （加盖公章处）
Legal representative (signature): (affix with the official stamp)
年 月 日
Year month date

29机构3（进口药品国外包装厂）：
The 3rd organization (foreign packers of the imported drug):

无
None

30机构4（进口药品注册代理机构）：
The 4th organization (import registration agent):

本机构负责缴费
The organization pays for the registration fee.

中文名称：××
Chinese name: ××

英文名称：××
English name: ××

组织机构代码^[7] ：××
Organization Code: ××

法定代表人：×× 职位：××
Legal representative: ×× Position: ××

注册地址：×× 邮编：××
Registered address: ×× code: ××

通讯地址：×× 邮编：××
Mailing address: ×× Zip code: 200050

注册申请负责人：×× 职位：××
The person responsible for registration: ×× Position: ××

联系人：×× 职位：××
Contact person: ×× Position: ××

电话：×× 传真：××
Tel: ×× Fax: ××

电子信箱：×× 手机：××
E-mail: ×× Cell phone: ××

法定代表人（签名）： （加盖公章处）
Legal representative (signature): (affix with the official stamp)
年 月 日
Year month date

[7]: In China, every organization is identified exclusively by an organization code. It’s not applicable for foreign organizations.

31委托研究机构：
Contract research organization:

32申报资料： ^[8]
Application dossier:

4号资料：4号资料_barcode.doc
Dossier No. 4: dossier No. 4_ barcode.doc

7号资料：7号资料_ barcode.doc
Dossier No. 7: dossier No. 7_ barcode.doc

8号资料：8号资料_ barcode.doc
Dossier No. 8: dossier No. 8_ barcode 3.doc

16号资料：16号资料_ barcode.doc
Dossier No. 16: dossier No. 16_ barcode.doc

28号资料：28号资料_ barcode.doc
Dossier No. 28: dossier No. 28_ barcode.doc

[8]: The application dossier is prepared and submitted by the registration agent accompanied with the application form.

PS.委托研究机构的缩写为CRO。

经审查，本表填写符合形式审查要求。 审查机关
After examination, the format of this application form is considered to be in accordance with the requirements. The examining authority

审查机关： 审查人签名： 日期： 年 月 日
The examining authority: the signature of the examiner: date: year month date

本表必须使用SFDA制发的申请表填报软件填写、修改和打印。不得涂改。数据核对码：**********
The application form must be filled in, amended or printed with the software provided by SFDA and shall not be altered. The bar code is **********.

若老外不清楚中国的形式审查, 可能误会accept相当于approve, 其实"受理"是指进入 under consideration 的阶段而已。 可能需要加注解了。