Series 2: Drug Drug Development requirements through the eyes of FDA

What are e-CTD? Understanding the various tools and softwares for Electronic submissions

The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions. FDA as a government agency does not recommend specific software or tools. Information on tools, vendors, and eCTD preparation firms may be obtained by Internet search. Its recommend that you choose eCTD software and tools that allows you to build, validate, and view an eCTD.

In addition, there are several non-profit organizations that sponsor conferences and offer training in eCTD, and FDA regularly participates in these events. The FDA would like to work closely with people who plan to provide a submission using the eCTD specifications. Ther first step after would be to submit a sample eCTD for evaluation- Submission Process.

Quick Tips:-

• Reviewing the Published Guidance and Specifications documents
• Viewing  recent eCTD presentations by FDA staff
• Refer to the Comprehensive Table of Contents Headings and Hierarchy for information on document location, and for a regulatory and CFR mapping to the CTD
• Don’t rush when submitting, since what can seem like a small error can have big implications (such as a wrong digit in your application number
• Dont forget to take advantage of the Electronic Submissions Gateway and use FDA fillable forms and digital signatures for the fastest processing of your electronic submissions see the eCTD validation specifications for more information. Review the most recent eCTD presentations by FDA staff so you’re aware of current recommendations.
  If you have questions along the way, please do not hesitate to contact the CDER Electronic Submission (CDER ESUB) Support Team at esub@fda.hhs.gov

eCTD Guidance and Specifications

Electronic Submissions Public Docket 

Request a Pre-assigned Application Number for a Planned eCTD Submission

Guidance Documents

• Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications (PDF - 132KB) (June 2008)
• Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (PDF - 98KB) (April 2009)
  • Clarification for question #10 of "ICH M4: The CTD -- Efficacy Q&As" on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format (9/12/2006)

eCTD Specifications

• FDA eCTD Table of Contents Headings and Hierarchy (PDF - 73KB) (updated 7/6/2005)
• eCTD Backbone Files Specification for Module 1 (PDF - 102KB) (updated 12/13/2006)
  •  eCTD Module 1 Website - Updated Module 1 documents and supporting files - not for implementation(updated 8/6/2012)
• eCTD Backbone File Specification for Modules 2 through 5 3.2.2 (PDF - 726KB) (updated 7/16/2008)
• The eCTD Backbone File Specification for Study Tagging Files 2.6.1 (PDF - 149KB) (6/3/2008)
• Study Data Specifications (PDF - 199KB) (updated 7/18/2012)
• eCTD Validation Specifications Website (12/20/2011)
• Portable Document Format Specifications (PDF - 37KB) (updated 1/20/2012)
• Transmission Specifications (PDF - 35KB) (updated 7/26/2012)
  

UTILS	Version	File Name	MD5 Checksum	Support Began	Support Ends
ICH eCTD DTD	3.2	ich-ectd-3-2.dtd	1d6f631cc6b6357f0f4fe378e5f79a27	11/2003
ICH-STF DTD	2.2	ich-stf-v2-2.dtd	0972c10a4dadf3df5d2f41b2026a4a5c	8/2003
US Regional DTD	2.01	us-regional-v2-01.dtd	9d09aa5ffdb44368416e287f9b0ddeeb	8/2003
US Regional Stylesheet	1.1	us-regional.xsl	b3bdeb93158b2a30faca4d943b89fba4	9/2003
ICH eCTD Stylesheet	2.0	ectd-2-0.xsl	3a07a202455e954a2eb203c5bb443f77	11/2004
ICH STF Stylesheet	2-2a	ich-stf-stylesheet-2-2a.xsl	7af15705b92a21ac1a19527cfc504245	5/2007
Valid Values xml	2.2	valid-values.xml	664f584d0631db0414e8789e2a06613b	8/2008

 

Important Note: CDER's Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications - DDMAC) does not accept submissions in eCTD format or via the Electronic Secure Gateway at this time.  If received, these submissions will be rejected by CDER.

 

Submission Addresses for Electronic Documents

Send all electronic submissions (except ANDAs) to:
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room 
5901-B Ammendale Road
Beltsville, MD 20705-1266

Send ANDA submissions to:Office of Generic Drugs
Generic Drugs (HFD-600)
Center for Drug Evaluation and Research 
Food and Drug Administration
Metro Park North VII
7620 Standish Place
Rockville, MD 20855

General Considerations

• CDER and the Center for Biologics Evaluation and Research (CBER) have co-published a guidance document called Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 288KB). This document provides general information about the electronic submissions process.
• For more information on guidance documents, please contact esub@fda.hhs.gov.
   

Abbreviated New Drug Applications (ANDAs)

Please refer to:

• Abbreviated New Drug Application (ANDA): Generics
• ANDA Checklist (PDF - 122KB)

Drug Master Files (DMFs)

DMFs should be submitted in eCTD or paper format only. Please refer to:

• Guidance for Industry: Drug Master Files (DMFs)
• For general DMF questions, please contact dmfquestion@cder.fda.gov.
• For more information on electronic submissions for DMF, please contact esub@fda.hhs.gov.

 Investigational New Drug Applications (INDs)

CDER accepts INDs submitted in eCTD or paper format.  Please refer to:

• Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 288KB)
• On March 26, 2002, FDA published the final guidance on the submission of INDs in electronic format to the Center for Biologics Evaluation and Research (CBER) (PDF - 80KB). Once the IND submission to CBER is posted on public docket 92S-0251, we will be capable of accepting INDs submitted to CBER in electronic format without paper copies. At this time, we are not extending this to INDs submitted to CDER.

 New Drug Applications (NDAs)

Please refer to:

• Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 288KB)

 FDA Electronic Submissions Gateway (ESG)

• FDA Electronic Submissions Gateway:CDER's preferred method of submission is via the FDA Electronic Submissions Gateway (ESG). For more information on the FDA ESG, see the Electronic Submissions Gateway page.
• Fillable Forms and Automated Processing:
  For automated processing of your submissions, submit an FDA fillable form with each submission. Using a fillable form with or without an additional signed scanned form (and no errors present in the submission) means the submission can be in the hands of the FDA Project Manager and Reviewers in as little as 10 minutes after it is successfully received by FDA via the ESG. This is applicable to both eCTD and non-eCTD submissions.
• Important Note:
  If, for some reason, you are unable to submit a fully completed fillable form, with an electronic signature, you could submit the completed fillable form (not scanned) without the signature and then provide a second 356h form that uses another method of signature (i.e., a scanned signature). When including a second complete 356h form, do not include "356h" anywhere in the file name. We recommend that you use a filename like "signed-form.pdf" or something similar, while the fillable form would be named "356h.pdf." This will allow our automated systems to correctly find your fillable form, read it, and process your submission appropriately.

 Electronic Document Room (EDR) / Physical Media

• Physical Media:
  When submitting via physical media, it is recommended that you submit a paper copy of the cover letter (with contact information) and FDA form in case the physical media proves to be unreadable. For more information, please refer to: Specification for Transmitting Electronic Submissions Using eCTD Specifications.
• All submissions on physical media should be sent to the EDR via the addresses at the top of this page. 
• Submissions on physical media are loaded and validated through the EDR.
• If you are submitting through the ESG, it is not necessary to also send physical media to the EDR.
• For more information on allowable file types or other questions dealing with electronic submissions,
• please contact: esub@fda.hhs.gov.

 

Declaration by the Blog owner:- All the information given above has been sourced out from the FDA website, for ease of young researchers to learn the method of drug registration process.