EU Accepted File Formats for eCTD
November 2023
This document provides details on which file formats are allowed when using eCTD
specifications. It is a list of accepted file types and the eCTD locations in which those file types
should be provided (the generally accepted file format is the PDF, however, is specific cases,
other formats will be exceptionally accepted in the eCTD modules).
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.
File Type File Format Format Name Expected Permissible Uses / Comments
Location(s) in eCTD
Documents
.pdf Portable Document Format M1 – M5 PDF/A highly recommended
.docx Microsoft Word Open XML M1.3, M1.8.2, M2 Labelling, RMP, Response to
document Questions, M2 summaries &
overviews
.txt Text file M5 Datasets
.xls Microsoft Excel document M5 Datasets
.xlsx Microsoft Excel Open XML M5 Datasets
document
Images
.bmp Bitmap Graphics M1.3.2, M1.3.3 Mock-Ups / Specimens
.gif Graphics Interchange Format M1.3.2, M1.3.3 Mock-Ups / Specimens
.jpg, .jpeg Joint Photographic Experts Group M1.3.2, M1.3.3 Mock-Ups / Specimens
.png Portable Network M1.3.2, M1.3.3 Mock-Ups / Specimens
Graphics
Audio/Video
.avi Audio Video Interleaved M1.3, M2, M5 Labelling, M2 summaries &
overviews, CSRs
.mpeg Moving Picture Experts Group M1.3, M2, M5 Labelling, M2 summaries &
overviews, CSRs
.mp4 MPEG-4 Part 14 M1.3, M2, M5 Labelling, M2 summaries &
overviews, CSRs
1
File Type File Format Format Name Expected Permissible Uses / Comments
Location(s) in eCTD
.wmv Windows Media Video M1.3, M2, M5 Labelling, M2 summaries &
overviews, CSRs
Coding
Language
.dtd Document Type Definition M1 (\util\dtd folder) \util\dtd folder
.xml Extensible Markup Language M1.2, M1.3, M4, M5 eAF, Labelling, Datasets, ePI
.xsd XML Schema Definition M4, M5 Clinical (ISS) datasets
.xsl Extensible Stylesheet Language M1, M4 - M5 \util\style folder, data
Data
.csv Comma Separated Values file M5.3.3.5 Population PK Studies
.svg Scalable Vector Graphics M3 – M5
.xpt SAS Transport file M3 – M5
References:
ICH Official web site : ICH -> File Format criteria document (m2-file-format-criteria-v1-november-
2014_3.pdf (ich.org))
