Bar Code^[1]                                                       原始編號

                                                                Original Application No. ^[2]

                                                                受理號

                                                                Handling No. ^[3]

國家食品藥品監(jiān)督管理局

STATE FOOD AND DRUG ADMINISTRATION

藥品注冊申請－境外申請人用表

DRUG REGISTRATION APPLICATION -- FOR FOREIGN APPLICANTS

                                                                            

聲明

STATEMENT

我們保證：

We guarantee:

(1) 本申請遵守《中華人民共和國藥品管理法》、《中華人民共和國藥品管理法實施條例》和《藥品注冊管理辦法》等法律、法規(guī)和規(guī)章的規(guī)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) 申請表內(nèi)容及所提交資料、樣品均真實、來源合法，未侵犯他人的利益，其中試驗研究的方法和數(shù)據(jù)均為本藥品所采用的方法和由本藥品得到的試驗數(shù)據(jù)；

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) 一并提交的電子文件與打印文件內(nèi)容完全一致。

The accompanied electronic version is in perfect accordance with the printed version.

如查有不實之處，我們承擔(dān)由此導(dǎo)致的一切法律后果。

We will take all the legal consequences of any false statements.

其他特別申明事項：對附加申請事項的說明：我公司代理申請進口的×××公司的××為已有國家藥品標(biāo)準(zhǔn)的品種，用于生產(chǎn)××制劑。根據(jù)《藥品注冊管理辦法》中“進口化學(xué)藥品申報資料和要求”，申請已有國家藥品標(biāo)準(zhǔn)的原料藥不需進行臨床試驗，故申請免做臨床試驗。

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.

 

申請事項

APPLICATION ITEMS

1 本申請屬于：進口注冊

This application is for: import registration

2 申報事項：臨床試驗

Application for: clinical trial

3 藥品注冊分類：化學(xué)藥品

Registration category: chemical drugs

4 附加申請事項：減或者免臨床研究

Supplemental application for: Waiver or less subject numbers for clinical trial

 

藥品情況

DRUG INFORMATION

5 藥品通用名稱：**

Generic name of the drug: **

6 通用名稱來源：藥典委員會

Source of the generic name: Chinese Pharmacopoeia Commission

7 英文名稱/拉丁名稱：**

English name/Latin name: **

8 漢語拼音：**

Chinese Phonetic Alphabet: **

9 化學(xué)名稱：**

  Chemical name: **

10其他名稱：

Other Names: 

11商品名：無

Drug Trade Name: none

12制劑類型：非制劑 原料藥

Product category: API

13規(guī)格：

Strength:

14同品種已被受理或同期申報的其他制劑及規(guī)格：

  Other dosage forms and strengths of the same drug handled by or submitted to SFDA by the same applicant:

15包裝：直接接觸藥品的藥包材：

Packing: immediate package material:

包裝規(guī)格：

Packing size:

16藥品有效期：**個月

  Shelf life: ** months

17處方（含處方量）：

  Formulation (including quantitative composition):

  活性成分/中藥藥味/…：

  Active ingredients/ Chinese medicinal materials /…:

18原/輔料來源：

Source of raw materials and excipients:

19中藥材標(biāo)準(zhǔn)：

Specifications of Chinese medicinal materials:

20藥品標(biāo)準(zhǔn)：藥品標(biāo)準(zhǔn)：自擬標(biāo)準(zhǔn)

  Specifications: specifications: in-house specifications

  來源：其它標(biāo)準(zhǔn)：企業(yè)標(biāo)準(zhǔn)

  Source of specifications: other specifications: in-house specifications

21適應(yīng)癥或功能主治：

  Indications or functions:

  適應(yīng)癥分類：

  Indication category:

  適應(yīng)癥：

  Indication:

 

相關(guān)情況

RELATIVE INFORMATION

22專利情況：專利權(quán)屬聲明：我們聲明：本申請對他人專利不構(gòu)成侵權(quán)。

  Patent information: patent declaration: we declare that this application does not infringe any other’s patent.

23是否涉及特殊管理藥品或成分：

Whether the drug is subject to special administration or contains any ingredients subject to special administration：

否

No

立項批復(fù)文件號^[4]：

The number of the official approval document of the proposal:

24中藥品種保護^[5]：

Drugs under application for TCM protection:

25同品種新藥監(jiān)測期^[6]：

  Monitoring period of new drugs of the same drug by other enterprises:

  無

  None

26本次申請為：首次申請

  This application is: initial application

 

申請人及委托研究機構(gòu)

APPLICANTS AND CONTRACT RESEARCH ORGANIZATIONS

27機構(gòu)1（境外制藥廠商）：

  The 1^st organization (foreign manufacturer):

  中文名稱：**

  Chinese name: **

  英文名稱：**

  English name: **

  法定代表人：** 職位：**

  Legal representative: ** Position: **

  注冊地址：**

  Registered address: **

  國家或地區(qū)：**

  Country or region: **

  注冊申請負責(zé)人：**    職位：**

  The person responsible for registration: **    Position: **

  電話：**   傳真：**

  Tel: **      Fax: **

  電子信箱：**

  E-mail: **

  法定代表人（簽名）：          （加蓋公章處）

  Legal representative (signature):    (affix with the official seal)

                                年    月     日

                                Year  month  date

28機構(gòu)2（進口藥品生產(chǎn)廠）：

  The 2^nd organization (manufacturer of the imported drug):

  中文名稱：**

  Chinese name: **

  英文名稱：**

  English name: **

  法定代表人：** 職位：**

  Legal representative: ** Position: **

  生產(chǎn)地址：**

  Manufacturing address: **

國家或地區(qū)：**

  Country or region: **

注冊申請負責(zé)人：**    職位：**

  The person responsible for registration: **    Position: **

  電話：**   傳真：**

  Tel: **      Fax: **

  電子信箱：**

  E-mail: **

  法定代表人（簽名）：          （加蓋公章處）

  Legal representative (signature):    (affix with the official stamp)

                                年    月     日

                                Year  month  date

29機構(gòu)3（進口藥品國外包裝廠）：

  The 3^rd organization (foreign packers of the imported drug):

  無

  None

30機構(gòu)4（進口藥品注冊代理機構(gòu)）：

  The 4^th organization (import registration agent):

  本機構(gòu)負責(zé)繳費

  The organization pays for the registration fee.

  中文名稱：**

  Chinese name: **

  英文名稱：**

  English name: **

  組織機構(gòu)代碼^[7]：**

  Organization Code: **

  法定代表人：**  職位：**

  Legal representative: **  Position: **

  注冊地址：**  郵編：**

  Registered address: ** Zip code: **

  通訊地址：**  郵編：**

  Mailing address: **  Zip code: **

  注冊申請負責(zé)人：**  職位：**

  The person responsible for registration: **  Position: **

  聯(lián)系人：**  職位：**

  Contact person: **  Position: **

  電話：** 傳真：**

  Tel: **    Fax: **

  電子信箱：**  手機：**

  E-mail: **      Cell phone: **

  法定代表人（簽名）：          （加蓋公章處）

  Legal representative (signature):    (affix with the official stamp)

                                年    月     日

                                Year  month  date

31委托研究機構(gòu)：

  Contract research organization:

32申報資料：^[8]

  Application dossier:

  4號資料：4號資料_barcode.doc

  Dossier No. 4: dossier No. 4_ barcode.doc

  7號資料：7號資料_ barcode.doc

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

8號資料：8號資料_ barcode.doc

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

16號資料：16號資料_ barcode.doc

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

28號資料：28號資料_ barcode.doc

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

 

經(jīng)審查，本表填寫符合形式審查要求。                                           審查機關(guān)

After examination, the format of this application form is considered to be in accordance with the requirements.                                                    The examining authority

審查機關(guān)：             審查人簽名：              日期：  年   月     日

The examining authority:   the signature of the examiner:  date:    year  month  date

本表必須使用SFDA制發(fā)的申請表填報軟件填寫、修改和打印。不得涂改。數(shù)據(jù)核對碼：**********

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.