Welcome

Hello and welcome to the educational presentation, Electronic

Common Technical Document (eCTD): Overview and Submission.
This training will walk you through the fundamentals of submitting
electronic submissions to the Center for Drug Evaluation and
Research (CDER).

We hope that you will take the time to:

 Go through each of the modules.

 Use the Resources tab to access specific information and
instructions about the electronic submission process.
 Refer to this training any time you have a question or concern
about how to submit electronically to CDER.

GOAL PURPOSE

The primary goal and purpose of CDER's training on electronic submissions is

to encourage sponsors to submit in electronic format using the eCTD format.

This training will explain the FDA's policies and practices regarding electronic
submissions and will help you take the appropriate steps to get your new and
old applications transitioned to the eCTD format

Course Objectives

Once you have completed this training, you should be able to:

 Identify how to transition from paper or non-eCTD format to

eCTD format.

 Identify the regulatory submissions that require the eCTD

format.

 Identify how to submit in eCTD format.

 Identify how to access and use the eCTD specifications and

guidance.

 Identify how to submit the eCTD via Electronic Submissions

Gateway or physical media.
Course Objectives (cont.)

Once you have completed this training, you should be able to:

 Identify the forms required as part of the application.

 Identify the validation checks needed to ensure compliance

with eCTD specifications.

 Identify the top reasons why FDA rejects eCTD submissions.

 Identify how to submit an eCTD sample.

 Identify how to request a pre-assigned application number

Navigating the Course

Let's take a few minutes to discuss the navigation elements that will

enrich content as you move through the course.

These navigation components include:

 FDA
 Small Business Assistance
 FDA/Drugs
 CDERLearn
 Resources
 FAQs
 Glossary
 Menu 
 Help
 D-Link
 Audio/Video Controls
 Back/Next Buttons

The image on the next page is a sample screen that shows examples
of the components, and provides a description of each.

Course Layout

You are currently reviewing the Introduction and Overview module.

Additional modules to be covered in the eCTD Overview and

Submission training include:
  Background on eCTD Standard. This module provides
background on the creation and implementation of the
Electronic Common Technical Document (eCTD).
 Submitting in eCTD Format. This module discusses how to
submit in eCTD format and utilize the eCTD specifications and
guidance.
 Transmitting Electronic Submissions to CDER. This module
discusses how to electronically transmit to CDER by Electronic
Submissions Gateway (ESG) or via Physical Media.
 Submitting FDA Forms with Submissions. This module
discusses which forms are required with submissions.

Also included are these modules:

 Validating eCTD Submissions. This module discusses how

submissions to CDER are validated, and how to ensure compliance
with eCTD specifications.
 Submitting an eCTD Sample. This module discusses the importance
of submitting a sample eCTD to FDA prior to actual submission.
 Requesting a Pre-Assigned Application Number. This module
discusses the function of the pre-assigned application number.
 Summary. This module provides a brief overview of what the course
covered.

In addition, there is a module for small businesses that currently are

submitting by paper and are looking to transition to electronic submission.

Module Summary

Congratulations! You have completed the Introduction and Overview

module.

Remember, the primary goal of this training is to encourage sponsors

to submit in electronic format using the eCTD format.

Avail yourself of the information in each of the modules, which

will help you take the appropriate steps to get your new and old
applications transitioned to the eCTD format.

This course will take 1 hour to complete. Let's get started!

Module Introduction/Objective

Welcome to the Background on eCTD Standard module. In this

module, you will learn the background of the creation and
implementation of the Electronic Common Technical Document
(eCTD) standard.

Review the graphic to the right that shows the objective for this
module.

To market a drug or biological product in the United States, you must

provide adequate information to the FDA demonstrating that the
product is safe and effective for the conditions prescribed,
recommended, or suggested in the proposed labeling for the product.

In 2003, the Center for Drug Evaluation and Research (CDER)

and the Center for Biologics Evaluation and Research (CBER) issued
the eCTD guidance and specifications following the development of
the eCTD by the International Conference on Harmonisation, also
known as ICH.

Module Introduction/Objective (cont.)

The eCTD specification marked the start of a transition to electronic

standards-based submissions. The eCTD format provides support for
all application types including:

 Investigational New Drug Application (IND)

 New Drug Application (NDA)
 Biologics License Application (BLA)
 Abbreviated New Drug Application (ANDA)
 Drug Master File (DMF)

Starting on January 1, 2008, CDER withdrew previous eNDA and

eANDA guidances, leaving eCTD as the only electronic submission
format for CDER.

eCTD is the preferred format for submitting applications to CDER.

eCTD Web Site

The eCTD Web site provides a wealth of information on the
submission of the eCTD including specifications and steps to follow
to help simplify the process.

The smallest error in a submission can have big implications. FDA

recommends that you plan and prepare well in advance for electronic
submission; do not rush!

If you have any questions, contact the CDER Electronic Submission

Support Team at [email protected].

=========

Summary

You have completed the Background on eCTD Standard module.

Let's take a minute to review the key points you have learned.

 The eCTD format provides support for all application types.

 eCTD is the preferred format for submitting applications to
CDER.
 The eCTD contains an electronic table of contents broken
down into five modules.
 The eCTD Web site provides a wealth of information on
submitting the eCTD including specifications and steps to
follow to help simplify the process.

odule Introduction/Objectives

Welcome to the Submitting in eCTD Format module. In this module,

you will learn how to submit in eCTD format and utilize the eCTD
specifications and guidance.
Review the graphic to the right that shows the objectives for this
module.

Specialized software is needed in order to compile documents into

eCTD format for submission. This usually involves software that
allows both publishing and viewing of the eCTD submission. Some
companies choose to outsource this process.

While the FDA does not endorse particular software or outsourcing

solutions, it is possible to easily identify firms that provide eCTD
products and services by doing a simple Web search on "eCTD
publishing."

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FDA eCTD Overview and Submission WBT

Submitting in eCTD Format

Is the eCTD Format Mandatory?

One question you may have is whether or not the eCTD format is
mandatory.

Mandatory compliance dates for eCTD format are shown below:

Submission Type Compliance Date  

NDAs, ANDAs, BLAs May 5, 2017
Commercial INDs, Master Files May 5, 2018  

For all of
these submission types, the sponsor must electronically submit any
amendments, supplements, and reports, even if the original
submission was submitted to FDA prior to implementation of the
electronic submission requirements.

Click on the question to the right to review the answer.

The FDA offers assistance to small businesses that plan to provide a
submission using the eCTD specifications. The FDA recommends that you
follow these steps to help simplify the process:

 Review the published guidance and specifications documents provided

on the eCTD Web site, located under the Resources tab.
 Submit an eCTD sample prior to submitting an actual eCTD
submission.
 Refer to the Comprehensive Table of Contents Headings and
Hierarchy on the eCTD Web site, a link to which is located under the
Resources tab.

Let's look at each of these steps in more detail.

REVIEW

Submissions Standards Guidance

Also review the eCTD Submission Standards for the latest guidance,

specifications, and validation.:

CTD Sample

FDA recommends that small businesses submit a successful eCTD

sample prior to submitting an actual eCTD submission.

While the sample submission is not considered an official

submission, it is one way that the FDA offers assistance to people
who plan to provide a submission using the eCTD specifications.
omprehensive Table of Contents Headings and Hierarchy

A table of contents is defined by headings arranged in a hierarchical

fashion.

See the associated specification, Comprehensive Table of Contents

Headings and Hierarchy, for the comprehensive listing of headings
and hierarchy. Because this is a comprehensive listing, not all
headings are applicable to all submissions or submission types.

All of the information you need to submit is covered by these

headings. If you think other headings are needed, you should contact
our electronic submission coordinators prior to using any other
headings.

Please also refer to the FDA Guidance for Industry: Providing

Regulatory Submissions in Electronic Format - Human
Pharmaceutical Product Applications and Related Submissions Using
the eCTD Specifications.

CTD Facts

It is important to remember the following eCTD facts:

 Once you convert to eCTD, you must continue submitting in

eCTD format.
 Only submit one electronic copy when you submit
electronically.
 You can transition to eCTD submission at any time without
prior consultation from your review division.
 Do not submit paper copies with eCTD submissions

odule Summary

You have completed the Submitting in eCTD Format module. Let's

take a minute to review the key points you have learned.

 Steps for submission of an eCTD include:

o Review the published guidance and specifications
documents provided on the eCTD Web site, located
under the Resources tab. 
 o Submit an eCTD sample prior to submitting the actual
eCTD. 
o Refer to the Comprehensive Table of Contents Headings
and Hierarchy.
 Once you convert to eCTD, you must continue submitting in
eCTD format. 
 Only submit one electronic copy when you submit
electronically. 
 You can transition to eCTD submission at any time without
prior consultation from your review division. 
 Do not submit paper copies with eCTD submissions.

Transmitting Electronic Submissions to CDER

 Introduction
 Video – Questions on Submission
 Transmitting via Electronic Submissions Gateway
 Check Your Understanding
 WebTrader
 Sending via Physical Media
 Check Your Understanding
 Summary
USER INSTRUCTIONS:
odule Introduction/Objective

Welcome to the Transmitting Electronic Submissions to CDER

module. In this module, you will learn how to electronically transmit to
the Center for Drug Evaluation and Research (CDER) by Electronic
Submissions Gateway (ESG) or via physical media.

Review the graphic to the right that shows the objective for this
module

VIDEO

wo Ways to Transmit a Submission

There are two ways you can electronically transmit a submission to

CDER:

 Electronic Submissions Gateway (ESG), which is the preferred

method
 Physical media, which could be a DVD/CD-ROM or USB drive
Transmitting via Electronic Submissions Gateway

The FDA Electronic Submissions Gateway  is an Agency-wide

solution for accepting electronic regulatory submissions and is the
required method of transmission for eCTDs 10GB or less.

The FDA ESG enables the secure submission of regulatory

information and is a conduit along which submissions travel to reach
their final destination. It does not open or review submissions; it
automatically routes them to the proper FDA Center.

You can transmit your eCTD INDs, NDAs, ANDAs, DMFs and BLAs

via the ESG.

Use of a fillable form is required, and can facilitate your submissions

being in reviewers' hands in as little as 15 minutes!

Transmitting via Electronic Submissions Gateway (cont.)

It is best to use fillable forms that are accessible from the FDA Web
site. You can view and download them here.

There are a variety of forms included in a fillable PDF or HTML

format, including forms such as:

 Form 1571 (IND)

 Form 356h (NDA)

ransmitting via Electronic Submissions Gateway (cont.)

For a successful gateway transmission, here are some

recommended steps:
 1. Submit a successful test gateway submission prior to
submitting via gateway
2. Use a FDA fillable form for automatic processing
3. Ensure that the us-regional.xml file is complete and correct,
checking the date, application #, sequence #, submission type,
and drug product for accuracy
4. Choose the appropriate center: CDER or CBER
5. WebTrader
6. Prior to using the ESG, a WebTrader account has to be
created by the small business owner. You should refer to
the Setting up a WebTrader Account Checklist Web site, which
you can access under the Resources tab. On the Web site is a
checklist to help you with the setup of an ESG account.
7. What is WebTrader? WebTrader is an applet that is
downloaded on to your PC, when you log on to the FDA ESG
Web page. It is part of the Axway COTS product suite that is
used at FDA.
8. WebTrader is a Web interface that copies and packages your
submission on your desktop in a secure fashion, transmits the
submission in a fully encrypted message to the FDA, and then
removes any traces of its presence from your PC.
9. For policy questions and to request a WebTrader account,
contact [email protected].
10. For assistance with the registration or testing process,
contact [email protected].

ou can also send your submission via physical media if it is greater than 10
GB. Only one electronic copy is required and it is recommended that you
submit a paper copy of the cover letter including the contact information and
FDA form, in case the media proves to be unreadable.

For more information on transmitting via physical media, refer to

the transmission specification document, which is located under the
Resources tab.

The link to the transmission specification is located in the eCTD Submission

Standards (under Quick Links on www.fda.gov/ectd).

Sending via Physical Media (cont.)

For a successful physical media submission, here are some

recommended steps:
 1. Send submissions to the Central Document Room as an official
submission for proper tracking and for security purposes; do
not send via email.
2. Submit a paper copy of the cover letter including the contact
information and FDA form, in case the physical media proves
to be unreadable.
3. Send one copy of the electronic submission.
4. Make sure to do a quality check of disks before submitting to
avoid blank media.
5. Do not send submissions directly to reviewers.
6. For additional information, refer to Specification for
Transmitting Electronic Submissions Using eCTD
Specifications prior to submitting via physical media.
7. Recognize that processing can take two to three days from
submission receipt.

dule Summary

You have completed the Transmitting Electronic Submissions to

CDER module. Let's take a minute to review the key points you have
learned.

 The FDA Electronic Submissions Gateway (ESG) is the

preferred method of transmission for eCTDs.
 You can also send your submission via physical media. Only
one electronic copy is required and it is recommended that you
submit a paper copy of the cover letter including the contact
information and FDA form, in case the media proves to be
unreadable.

Submitting FDA Forms with Submissions

 Introduction
 Video – Required Forms
 More Information on Required Forms
 Check Your Understanding
 Summary

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FDA eCTD Overview and Submission WBT

Submitting FDA Forms with Submissions

Module Introduction/Objective

Welcome to the Submitting FDA Forms with Submissions module. In

this module, you will learn which forms should be included with
electronic application submissions to FDA.

Review the graphic to the right that shows the objective for this
module.

This module answers the question, "Which forms are required as part
of the eCTD submission?"

Required Forms

Just as with paper submissions, all electronic application

submissions to FDA must include an appropriate FDA form.

You might be wondering, "Are the forms that I submit when applying
electronically different than the forms I use when applying by paper?"

There are no additional forms that need to be submitted with an

electronic submission versus a paper submission.

Let's check in with Anthony and Carmen, who are filling out the
required forms for their new drug. What questions might they have
about required forms?

equired Forms

An Investigational New Drug (IND) application is a request for FDA to

administer an investigational drug to humans. Sponsors submitting
INDs should include Form 1571.

For guidance on Form 1571, and to download a fillable PDF, select

this link.
To apply to market a new drug, biologic, or an antibiotic drug for
human use, you need to complete Form 356h. Form 356h includes
information such as applicant information, proposed indication,
establishment information, and more.

Sponsors submitting New Drug Applications (NDAs), Biologics

License Applications (BLAs), and Abbreviated New Drug Applications
(ANDAs) need to include Form 356h.

For guidance on Form 356h, and to download a fillable PDF, select

these links.

Module Summary

You have completed the Submitting FDA Forms with

Submissions module. Let's take a minute to review the key points you
have learned.

 Required forms when submitting in eCTD format include Form

1571 (for INDs) and Form 356h (for NDAs, BLAs, and ANDAs).
 Always use the fillable form to avoid delays in processing

Validating eCTD Submissions

 Introduction
 Validation Checks
 Why Are Submissions Rejected?
 Check Your Understanding
 Summary
 Module Introduction/Objectives
 Welcome to the Validating eCTD Submissions module. In this
module, you will learn which validation checks are needed to
ensure compliance with eCTD specifications, as well as the top
reasons why FDA rejects eCTD submissions.
 Review the graphic to the right that shows the objectives
for this module.
 Validation is an important processing component, and should
be done on all eCTD submissions regardless of the method of
submission.
 Let's take a look at how to best ensure compliance with eCTD
specifications.

Validation Checks
Validate all eCTD submissions prior to sending to the FDA.

FDA may perform additional validation checks for both eCTD and
non-eCTD submissions to ensure that submissions are processed
and routed accurately and in a timely fashion.

Additional validation checks include:

 Ensuring that the application form submitted matches the

application type specified in the us-regional.xml file, e.g., the
us-regional.xml specified application type is NDA but the
sponsor has submitted a form 1571.
 Ensuring the consistency of the application number specified in
the us-regional.xml file and application form.

What additional guidance is available on validation?

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Validating eCTD Submissions

Validation Checks (cont.)

"Validation checks" is an intimidating phrase, but the FDA's intent

here is to ensure that your submission is accurately and timely
routed. More information about FDA's validation checks may be
found online. Select each link below to view a PDF of the relevant
guidance.

Document Description
This document provides guidance about
Guidance for Industry Providing
how the FDA determines the receipt date
Regulatory Submissions in
of submissions provided in electronic
Electronic Format – Receipt Date
format.
Specifications for eCTD This document details the validation
Validation Criteria criteria applied when FDA processes
eCTD submissions. The document is
 located in the eCTD Submission
Standards (under Quick Links
on www.fda.gov/ectd).

Why Are Submissions Rejected?

You invest a great deal of time in your eCTD submissions. The last
thing you want to happen is for your submission to be rejected. What
are the top reasons that eCTD submissions get rejected?

Error Possible Cause

Duplicate sequence submission The sequence number was previously
received submitted.
The application number in the us-
us-regional.xml/form mismatch regional.xml and the application
number on the FDA form did not match.
Submission sent to the wrong The submission was meant for CBER
Center but inadvertently sent to CDER.
There were no files/data in the folder
No data received
submitted.
The files submitted were corrupted
Corrupted or broken media
and/or physical media were broken and
received
could not be read.
There was no us-regional.xml file or
Submission is not in standard
index.xml file provided with the
eCTD format
submission.

FDA uses a commercial off-the-shelf product to validate eCTD

submissions. For more information, review Specifications for eCTD
Validation Criteria.

odule Summary

You have completed the Validating eCTD Submissions module. Let's

take a minute to review the key points you have learned.

 FDA may perform additional validation checks for both eCTD

and non-eCTD submissions to ensure compliance with eCTD
specifications.
 FDA rejects technically deficient eCTD submissions. For more
information, review Specifications for eCTD Validation Criteria.
Submitting an eCTD Sample
 Introduction
 Video – Submitting a Successful Sample
 Submitting a Sample eCTD
 Sample Recommendations – Flowchart
 Where to Send Sample Materials
 Check Your Understanding
 Summary
 Module Introduction/Objective
 Welcome to the Submitting an eCTD Sample module. In this
module, you will learn why the FDA recommends that sponsors
submit a successful eCTD sample prior to submitting an actual
eCTD submission.
 Review the graphic to the right that shows the objective
for this module.
 While the sample submission is not considered an "official"
submission, FDA would like to work closely with those who
plan to provide a submission using the eCTD specifications.
 Partnering on the sample will help smooth the process when it
comes time to make the real submission.

VIDEO

ubmitting a Sample eCTD

Submitting a sample eCTD ahead of the actual eCTD has many

benefits. While it does not involve any FDA review of the submission
content, it is very effective at resolving technical issues.

How do you go about submitting a sample?

The first thing to do is to obtain a sample application number from the

Electronic Submissions Team at
[email protected], which you should only use for the sample
and not for your actual eCTD submission.

Please follow instructions on submitting a sample from this Web site.

Submitting a Sample eCTD (cont.)

Once you have your sample application number and your eCTD
prepared, send your sample submission via physical media to the
Center for Drug Evaluation and Research (CDER).

Sample eCTDs are evaluated by the Electronic Submissions staff for

compliance with eCTD specifications, display, organization,
navigation, and reviewability of the documents. You need to provide
some bookmarks, proper placement of files, proper use of attributes,
use of valid values, and descriptive leaf titles in your sample.

You may have to wait up to 30 days to receive feedback on your

sample, but in most cases you can expect an answer sooner than
that. After you have received and implemented the feedback, you
should be technically ready to submit to the Agency in eCTD format.

FDA Recommendations for Sample Submission

 FDA recommends the following about a sample submission:

 First, obtain a sample application number by emailing esub-

[email protected].
 Be sure to allow time for feedback on your sample eCTD, as
there can be up to a 30-day turnaround time.
 Once received, the sample is reviewed by the ESUB staff – not
by an FDA reviewer.
 ESUB staff look for the following elements:
o Compliance with specifications
o eCTD validation and display
o Organization, navigation, and reviewability of the
submission
 When providing the sample, refer to recommended contents of
the sample submission document,
which is available under the Resources tab.
 Read about Submitting an eCTD or Standardized Data Sample
to the FDA.
 You should send the sample via physical media. The sample
should not be sent via the test gateway.
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 

 FDA eCTD Overview and Submission WBT

 Submitting an eCTD Sample

 Where to Send eCTD Sample Materials

 Remember, you can always refer to Sample Submission
Process and Recommended Contents of the Sample
Submission Web pages, links to which can be found in the
Resources tab, for more information.
 When you believe your sample is ready to be submitted, send
it via physical media to:


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Electronic Common Technical Document (eCTD):

Overview and Submission

Requesting a Pre-Assigned Application Number

 Introduction
 Application Number – Definition
 Video – Pre-Assigned Application Numbers
 Frequently Asked Questions
 Summary
  Module Introduction/Objective
 Welcome to the Requesting a Pre-Assigned Application
Number module. In this module, you will learn how to request a
pre-assigned application number.
 Review the graphic to the right that shows the objective
for this module.
 If you plan to submit your application to CDER in eCTD format,
you will need to request a pre-assigned application number for
all application types prior to submitting in eCTD format.
 pplication Number – Definition
 What exactly is a pre-assigned application number?
 A pre-assigned application number is a unique six-digit
number, e.g., 012345, assigned to sponsors to enable them
to identify their application.
 The FDA requires that you use this number any time you
submit an eCTD application.
 Before you request a pre-assigned eCTD application number,
you need to apply for a secure email address with the FDA by
contacting [email protected].
 Click here for more information on how to obtain the pre-
assigned application number.
 Coding Pre-IND Submissions
 Q: Can pre-IND submissions be submitted to CDER via the
ESG under the pre-IND application number as sequence
number 0000? 

A: Any information submitted in eCTD format utilizing us-

regional DTD v2.01 or v3.3 before the “original-application”
should be coded as "pre-submission" and should start with
sequence 0001. A high submission sequence series (e.g.,
9000) should not be used. If utilizing DTD v3.3, code as
submission-type “original application” and submission subtype
“pre-submission.” The original application will use the next
available sequence number depending on the number of
submitted “pre-submissions.

ubmitting PDF Files

Q: Can I submit .pdf files by themselves?

A: No.  Currently, the only acceptable electronic format for submitting

applications to CDER is using the
eCTD structure, which is submitted with an xml backbone.

Transitioning to eCTD (From Paper or Non-eCTD Format)

 Introduction
 Video – Transitioning from Paper
 Resubmission of Materials
 Steps in the Transition
 Check Your Understanding
 Summary