Submitting DMF using electronic common technical documents (eCTD)
发布日期：2018-07-19
n Basic Preparation before submission
n DMF preparation
n Submission of DMF with eCTD format
Above-mentioned three parts are described as follows:
1. Basic Preparations before submission
1.1 Apply for ESG production account
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Step 1: Apply for a secure e-mail for contacting FDA |
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Note: The e-mail for contacting FDA is dedicated for one person for contacting FDA and applying for ESG production account, and can not be used by others |
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Step 2: Apply for ESG test account |
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Note: The following information should be sent to ESGHelpDesk@fda.hhs.gov by secure e-mail: A. application purpose for ESG account B. Submission Method: WebTrader C. PDF of signed Letter of Non-Repudiation Then FDA will send e-mail including username and password to you and guide you to register online for a TEST ACCOUNT in http://esgtestreq.preprod.fda.gov/ |
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Step 3: Apply for digital certificate |
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Note: Apply for digital certificate from https://www.globalsign.com/en/fda-esg/esg/, PersonalSign 2 Pro is priority to be chosen, then register with contact person and secure e-mail according to guidance, pay for digital certificate, download digital certificate and remember the password of it, install the digital certificate in computer used for submission of DMF. |
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Step 4: Apply for ESG production account |
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Note: Login in https://esgtest.fda.gov/inbox with your test account and password, then send folder with small PDF document to FDA with your digital certificate and password after selecting center as GWTEST, submission type as ConnetTest, If delivery is successful, acknowledgement letter will be sent to you by FDATEST. Finally, you should send additional e-mail to ESGHelpDesk@fda.hhs.gov for applying for production account. FDA will give you a production account and temporary password, you should login in and set your new password. Until now, your production account is available. |
1.2 Apply for Pre-assigned DMF number
Pre-assigned DMF number should be applied from CDERAPPNUMREQUEST@fda.hhs.gov, pre-assigned DMF number should be contained in cover letter and used as name of folder for submitted to FDA via ESG.
The following information should be sent to FDA during application of Pre-assigned DMF number:
n Name of applicant and manufacturing site:
n Address of applicant and manufacturing site:
n Contact information (Contact Person, Phone, Fax. E-mail)
n Subject of Master File: That is name of product
n CAS registry number:
n Main use:
CDER will give you a 6-digital Pre-Assigned DMF number, e.g.: 032918.
1.3 Apply for Data Universal Numbering System Number (DUNS Number)
IF eCTD using us-regional v2.01 was created, DUNS Number is not necessary. If eCTD using us-regional v3.3 was created, DUNS Number is needed. eCTD using us-regional v3.3 is prior to be used because us-regional v3.3 is latest version software and DUNS Number is useful for ANDA.
DUNS Number can be purchased from http://www.fda-cv.com/fdazc/423.html, the fee is approximately 3000CNY, the application duration is 7days.
2. DMF preparation
The contents and format of DMF are described as follows:
2.1 The contents of DMF
The contents of DMF contain as follows:
n Module 1: Administrative Information and Prescribing Information
Ø 12-cover-letter
Cover letter include statement of commitment, statement of compliance with cGMP, which can be attachments of cover letter.
Ø 133-debarment-certification
Ø 1142-final-labeling
Ø 11214-environmental-analysis
Ø 141-letter of authorization
If you have no customer, letter of authorization is not needed.
n Module 2: Quality Overall Summary (QOS)
Ø 23-qos
n Module 3: Quality
Ø 32s-drug-sub
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Name of folder |
Contents in the folder |
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32s1-gen-info |
general-properties |
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nomenclature |
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structure |
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32s2-manuf |
manufacturer |
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manuf-process-and-controls |
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control-of-materials |
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control-critical-steps |
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process-validation |
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manuf-process-development |
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32s3-charac |
elucidation-of-structure |
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impurities |
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32s4-contr-drug-sub |
32s41-spec |
specification |
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32s42-analyt-proc |
analytical-procedures |
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32s43-val-analyt-proc |
validation-analyt-procedure |
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32s44-batch-analys |
batch-analyses |
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32s45-justif-spec |
justification-of-specification |
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32s5-ref-stand |
reference-standards |
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32s6-cont-closure-sys |
container-closure-system |
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32s7-stab |
stability-summary |
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postapproval-stability |
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stability-data |
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Ø 32r-reg-info
production-batch-records includes at least one executed batch records (in English and its original records) for drug substances or drug products.
2.2 The format of DMF
n Paper size: letter 22×28cm 8.5″×11″
n Font: Times New Roman, 12
n For PDF documents of five pages or longer, provide proper bookmarks, tables of contents, and hyperlinks
n PDFs must follow the FDA PDF specifications
n Do not submit paper copies of the application when submitting in eCTD format
n Each page contains sequence number, application date, company name, file name and its number, page number.
3. Submission of DMF with eCTD format
3.1 Generating DMF with eCTD format
n Input all information in eCTD software
n Test all information
n Obtain final DMF with eCTD format
3.2 Submission of DMF with eCTD format
n Login your ESG production account in https://esg.fda.gov/login
n Send documents
Select center as CDER, submission type as eCTD, use your digital certificate.pfx and password.
n Acknowledgement from CDER
When your submission is successful, CDER will send two acknowledgements to your ESG production account.
Foshan RuiTong Consulting Co.,Ltd. (Abbreviated as RuiTong) is a GMP consulting and execution company located in Foshan City, Guangdong Province, China. Its main services include GMP consulting and execution, DMF/CEP/ASMF registration and CFDA Drug registration, audit.
Looking forwarding to your feedback and cooperation with you.
Foshan RuiTong Consulting Co.,Ltd.
www.gdruitong.cn