FDA Module 1 Electronic Common Technical Document (eCTD)

v4.0 Implementation Package History v1.4

The following tables list the files included in the FDA Module 1 Electronic Common Technical
Document (eCTD) v4.0 Implementation Package and notes for the changes made in this version
of the package.

MAIN IMPLEMENTATION DOCUMENTS

Document Title Document File Name File Format Release Notes
Version
FDA Module 1 v1.4 USFDA_eCTD_v4_ Adobe Acrobat Revised based on
Electronic 0_Module1_IG_v1_ (PDF) consistency review of
Common Technical 4.pdf eCTD v4.0 references
Document (eCTD) (e.g., updated
v4.0 excluded elements for
Implementation applicant) and
Guide notation of elements
and attributes. No
substantive changes
have been made in
this version.
USFDA eCTD v4.0 v1.3 USFDA_Regional_ Excel Revised version.
Controlled CV_eCTD_4_v1_3. Updated for IG v1.4
Vocabulary (CV) xlsx changes.
USFDA OID v1.4 USFDA_OID_Listin Excel Revised version.
Listing g_v1_4.xlsx Updated for IG v1.4
changes.
ICH eCTD v3.2.2 v1.2 USFDA_Regional_ Excel Revised version.
Transition Mapping CV_TMM_DTD2_0 Updated for IG v1.4
Message Controlled 1_v1_2.xlsx changes.
Vocabulary for
DTD v2.1
ICH eCTD v3.2.2 v1.3 USFDA_Regional_ Excel Revised version.
Transition Mapping CV_TMM_DTD3_3 Updated for IG v1.4
Message Controlled _v1_3.xlsx changes.
Vocabulary for
DTD v3.3

1
REGIONAL GENERICODE CV FILES
Document Title Document File Name File Release Notes
Version Format
USFDA_eCTD_v4_0_CV
Genericode v1.0 genericode.xsd XML
Schema Schema
eCTD Codelist v1.0 USFDA_eCTD_Codelist Stylesheet
Stylesheet .xls
USFDA code list v1.0 usfda-logo.png Image
Application Type v2.0 USFDA CL1- XML
application-type.gc2.xml
Context of Use v4.0 USFDA CL2-context-of- XML Revised version.
use.gc4.xml Updated keyword
mappings (e.g. issue-
date) and remarks.
US CoU Keyword v1.0 USFDA CL3-cou- XML
Definition Type keyword-definition-
type.gc.xml
Form Type v4.0 USFDA CL5-form- XML Revised version.
type.gc4.xml Updated form types to
include Form 2253.
Promotional v1.0 USFDA CL6- XML
Document Type promotional-document-
type.gc.xml
Promotional v1.0 USFDA CL7- XML
Material Audience promotional-material-
Type audience-type.gc.xml
Promotional v2.0 USFDA CL8- XML
Material Type promotional-material-
type.gc2.xml
Submission v2.0 USFDA CL11- XML
Contact Type submission-contact-
type.gc2.xml
Submission Type v3.0 USFDA CL12- XML
submission-type.gc3.xml
Submission Unit v1.0 USFDA CL13- XML
Type submission-unit-
type.gc.xml
Submission contact v1.0 usfda-submission- XML
status contact-status.gc.xml
Submission Unit v1.0 usfda-submission-unit- XML
Status status.gc.xml
Telecom v1.0 usfda-telecom- XML
Capabilities capabilities.gc.xml

2
 Document Title Document File Name File Release Notes
Version Format
Telecom Use v1.0 usfda-telecom- XML
use.gc.xml
v3.2.2. eCTD Transition Mapping Message DTD v2.1
Genericode v1.0 genericode.xsd XML
Schema Schema
eCTD Codelist v1.0 USFDA_eCTD_Codelist Stylesheet
Stylesheet .xls
USFDA code list v1.0 usfda-logo.png Image
Application Type v2.0 USFDA CL1- XML
application-type-
tmm2_01.gc2.xml
Context of Use V1.0 USFDA CL2-context-of- XML
use-tmm2_01.gc.xml
Submission v2.0 USFDA CL11- XML
Contact Type submission-contact-
type-tmm2_01.gc.xml
Submission contact v1.0 usfda-submission- XML
status contact-status-
tmm2_01.gc.xml
Submission Unit v1.0 usfda-submission-unit- XML
Status status-tmm2_01.gc
v3.2.2. eCTD Transition Mapping Message DTD v3.3
Genericode v1.0 genericode.xsd XML
Schema Schema
eCTD Codelist v1.0 USFDA_eCTD_Codelist Stylesheet
Stylesheet .xls
USFDA code list v1.0 usfda-logo.png Image
Application Type v2.0 USFDA CL1- XML
application-type-tmm3-
3.gc2.xml
Context of Use v4.0 USFDA CL2-context-of- XML Revised version.
use-tmm3-3.gc4.xml Updated keyword
mappings (e.g. issue-
date) and remarks.
CoU Keyword v1.0 USFDA CL3-cou- XML
Definition Type keyword-definition-
type-tmm3-3.gc
Form Type v3.0 USFDA CL5-form-type- XML Revised version.
tmm3-3.gc3.xml Updated form types to
include Form 2253.
Promotional v1.0 USFDA CL6- XML
document type promotional-document-
type-tmm3-3.gc.xml

3
 Document Title Document File Name File Release Notes
Version Format
Promotional v1.0 USFDA CL7- XML
material audience promotional-material-
type audience-type-tmm3-
3.gc.xml
Promotional v2.0 USFDA CL8- XML
material type promotional-material-
type-tmm3-3.gc2.xml
Submission V2.0 USFDA CL11- XML
Contact Type submission-contact-
type-tmm2_01.gc2.xml
Submission contact v1.0 usfda-submission- XML
status contact-status-
tmm2_01.gc.xml
Submission Unit v1.0 usfda-submission-unit- XML
Status status-tmm2_01.gc

XML SAMPLE FILES (CONTAINED IN THE USFDA REGIONAL MODULE 1 XML

SAMPLES FOLDER)
Folder Name Version Folder Contents Release Notes
NDA Original v1.2 submissionunit.xml and Updated for v1.4 changes
submission unit sample content including OIDs for updated IG
versions and CV, and fixed
issue with CoU codes for
Cover Letter and Form.
Grouped Labeling v1.2 submissionunit.xml and Updated for v1.4 changes
Supplement submission unit sample content including OIDs for updated IG
versions and CV.
Grouped Labeling v1.2 submissionunit.xml and Updated for v1.4 changes
Supplement submission unit sample content including OIDs for updated IG
Amendment versions and CV.
Promotional v1.2 submissionunit.xml and Updated for v1.4 changes
Materials submission unit sample content including OIDs for updated IG
versions and CV, and updated
form type and added
additional CoU for 2253
submissions.
Withdraw v1.2 submissionunit.xml and Updated for v1.4 changes
Promotional submission unit sample content including OIDs for updated IG
Materials versions and CV.
V3.2.2 TMM v1.2 submissionunit.xml and Updated for v1.4 changes
submission unit sample content including OIDs for updated IG
versions and CV.