Bar Code[1] 原始编号
Original Application No. [2]
受理号
Handling No. [3]
国家食品药品监督管理局
STATE FOOD AND DRUG ADMINISTRATION
药品注册申请－境外申请人用表
DRUG REGISTRATION APPLICATION -- FOR FOREIGN APPLICANTS
声明
STATEMENT
我们保证：
We guarantee:
(1) 本申请遵守《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》和《药品注册管理办法》等法律、法规和规章的规定；
This application complies with laws and regulations such as Drug Administration Law of The People’s Republic of China, Implementing Regulation of the Drug Administration Law of The People’s Republic of China, and Drug Registration Regulation;
(2) 申请表内容及所提交资料、样品均真实、来源合法，未侵犯他人的利益，其中试验研究的方法和数据均为本药品所采用的方法和由本药品得到的试验数据；
The content of this application form, the submitted dossier and the samples are true and legal, without infringing any other’s rights. All the test methods and data are obtained from the drug we’re applying for;
(3) 一并提交的电子文件与打印文件内容完全一致。
The accompanied electronic version is in perfect accordance with the printed version.
如查有不实之处，我们承担由此导致的一切法律后果。
We will take all the legal consequences of any false statements.
其他特别申明事项：对附加申请事项的说明：我公司代理申请进口的×××公司的××为已有国家药品标准的品种，用于生产××制剂。根据《药品注册管理办法》中“进口化学药品申报资料和要求”，申请已有国家药品标准的原料药不需进行临床试验，故申请免做临床试验。
Other statements: Explanation for the supplemental application: We act as the agency of *** company for the import registration of **, a drug substance with available National Drug Standards in China which is used to produce ** preparations. According to the requirements on imported chemical drugs by Drug Registration Regulation, no clinical trial is needed for the application of drug substances with available National Drug Standards in China. Therefore we apply for omitting the clinical trials.
申请事项
APPLICATION ITEMS
1 本申请属于：进口注册
This application is for: import registration
2 申报事项：临床试验
Application for: clinical trial
3 药品注册分类：化学药品
Registration category: chemical drugs
4 附加申请事项：减或者免临床研究
Supplemental application for: Waiver or less subject numbers for clinical trial
药品情况
DRUG INFORMATION
5 药品通用名称：**
Generic name of the drug: **
6 通用名称来源：药典委员会
Source of the generic name: Chinese Pharmacopoeia Commission
7 英文名称/拉丁名称：**
English name/Latin name: **
8 汉语拼音：**
Chinese Phonetic Alphabet: **
9 化学名称：**
Chemical name: **
10其他名称：
Other Names:
11商品名：无
Drug Trade Name: none
12制剂类型：非制剂 原料药
Product category: API
13规格：
Strength:
14同品种已被受理或同期申报的其他制剂及规格：
Other dosage forms and strengths of the same drug handled by or submitted to SFDA by the same applicant:
15包装：直接接触药品的药包材：
Packing: immediate package material:
包装规格：
Packing size:
16药品有效期：**个月
Shelf life: ** months
17处方（含处方量）：
Formulation (including quantitative composition):
活性成分/中药药味/…：
Active ingredients/ Chinese medicinal materials /…:
18原/辅料来源：
Source of raw materials and excipients:
19中药材标准：
Specifications of Chinese medicinal materials:
20药品标准：药品标准：自拟标准
Specifications: specifications: in-house specifications
来源：其它标准：企业标准
Source of specifications: other specifications: in-house specifications
21适应症或功能主治：
Indications or functions:
适应症分类：
Indication category:
适应症：
Indication:
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：
Whether 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 of the same drug by other enterprises:
无
None
26本次申请为：首次申请
This application is: initial application
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: **
法定代表人（签名）： （加盖公章处）
Legal representative (signature): (affix with the official seal)
年 月 日
Year month date
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: ** Zip code: **
通讯地址：** 邮编：**
Mailing address: ** Zip code: **
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
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
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 **********.
[1]: The bar code is created randomly by the software. Each time the application form is amended, a new bar code will be created.
[2], [3]: To be given by SFDA after the application is handled.
[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.
[7]: In China, every organization is identified exclusively by an organization code. It’s not applicable for foreign organizations.
[8]: The application dossier is prepared and submitted by the registration agent accompanied with the application form.
