Specifications for File Format Types Using eCTD Specifications

Specifications for File Format Types Using eCTD Specifications

Revision History
Date Version Summary of Changes
2013-04-11 1.0 Initial version
2017-03-02 2.0 Updated version, new file formats added:
• Document file types: .xls, .xlsx
• Audio/Visual file types: .fla, .f4v, .mpg
• Data file types: .csv
• Modelling & Simulation file types: .cmp, .wks, .lbr
• Modelling & Simulation Reporting file types: .lua, .sas, .r, .ctl

2017-11-15 3.0 Updated .doc and .docx accepted locations

2019-08-19 4.0 Updated .doc and .docx accepted locations

1
 Specifications for File Format Types Using eCTD Specifications

Specifications for File Format Types Using eCTD Specifications

This document provides specifications for submitting file format types using eCTD
specifications. It is a list of accepted file types and the eCTD locations in which those file types
should be provided.

I. General Information

Documents should be provided in PDF searchable format. Images and other document
types should be rendered into PDF format and retain searchable text whenever possible.
Additional information related to PDF documents is available in the FDA technical
specification FDA Portable Document Format (PDF) Specifications.

II. Acceptable File Formats for Use in eCTD

In most cases, files submitted in formats below should also be provided in PDF format for
archival purposes, please reference the “Archive Format Copy” column to see if an alternative
version of the document should also be provided.
Accepted Archive
File Permissible
File Type Format Name location in Format Copy
Format Uses
eCTD
Documents
Portable
.pdf Document M1 – M5
Format
Microsoft Word M1.14, 1.16
.doc
document M2.3, M2.7 PDF ANDA
Microsoft Word
M1.14, 1.16
.docx Open XML
document M2.3, M2.7 PDF ANDA
.txt Text file M3 - M5
Microsoft Excel PDF
.xls M3 – M5
document
Microsoft Excel PDF
.xlsx Open XML M3 – M5
document
Images
Bitmap
.bmp M1.15
Graphics
Graphics
Package Insert
.gif Interchange M1 - M5
in draft labeling
Format
Joint
.jpg, .jpeg Photographic M1 – M5
Experts Group
Portable
.png M1 – M5
Network

2
 Specifications for File Format Types Using eCTD Specifications
Accepted Archive
File Permissible
File Type Format Name location in Format Copy
Format Uses
eCTD
Graphics
Audio/Video

.au Audio file M1.15

Audio Video
.avi M1.15
Interleaved
Macromedia Playable with
.flv, .fla,
Flash Source M1.15 Adobe
.f4v
File Acrobat*
.mpg,
MPEG-1 M1.15
.mpeg
MPEG-1 Audio
Layer II,
.mp2 M1.15
MPEG-2 Audio
Layer II
MPEG-1 Audio
Layer III,
.mp3 M1.15
MPEG-2 Audio
Layer III
MPEG-4 Part
.mp4 M1.15
14
Playable with
Shockwave
.swf M1.15 Adobe Acrobat
Flash file
*
Waveform
.wav M1.15
Audio File
Windows
.wma M1.15
Media Audio
Windows
.wmv M1.15
Media Video

Coding Language

Cascading Style M1.15, M4

.css
Sheets – M5
Document Type
.dtd \util\dtd folder
Definition M1
Hypertext
.htm, .html Markup M1.15
Language
Extensible
M1.14, M4
.xml Markup Labeling, Data
- M5
Language
XML Schema M1, M4 -
.xsd
Definition M5
.xsl Extensible M1, M4 - \util\style folder,
3
 Specifications for File Format Types Using eCTD Specifications
Accepted Archive
File Permissible
File Type Format Name location in Format Copy
Format Uses
eCTD
Stylesheet M5 data
Language
Data
Comma
.csv Separated M5.3.3.5 CDER Only
Values file
Scalable Vector TXT
.svg M3 – M5
Graphics
SAS Transport
.xpt M3 – M5
file
Modelling and
Simulation
.cmp SimCYP drug M5
CDER Only
model file
.wks SimCYP M5
CDER Only
workspace file
.lbr SimCYP M5
CDER Only
population file
Modelling and
Simulation
Reporting
.lua SimCYP PD M5
CDER Only
script
.sas SAS Script file M3-M5
.r R Script file M3 – M5 CDER Only
.ctl NONMEM M5
model control CDER Only
stream
*Playable with Adobe Acrobat without the need for additional plug-in

References:
References are available on the eCTD Web Page: http://www.fda.gov/ectd

ICH M2 EWG technical specification, Electronic Common Technical Document

Specification

FDA Guidance for Industry, Providing Regulatory Submissions in Electronic

Format — Human Pharmaceutical Product Applications and Related Submissions
Using the eCTD Specifications

Portable Document Format (PDF) Specifications

eCTD Backbone Files Specification for Module 1 (versions 1.3 and 2.3)

eCTD Backbone File Specification for Modules 2 through 5 3.2.2

The eCTD Backbone File Specification for Study Tagging Files 2.6.1
4
 Specifications for File Format Types Using eCTD Specifications

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-
Electronic Format – Promotional Labeling and Advertising Materials for Human
Prescription Drugs

Study Data Technical Conformance Guide

Questions may be sent to:

CDER: [email protected]
CBER: [email protected]
Data-related questions: [email protected]