How To Fix Common eCTD Validation Issues

Previously, we looked at issues that arise within eCTD.  Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in this article.  The article looks at Module 1 specification issues and more.

We have outlined some additional guidance on eCTD validation errors seen that may help you in your journey with eCTD format.

Module 1 specification issues: Specific standards have been defined for the EU Module 1 Specification and when they are not followed validation errors can occur.  For example, using an out of date module 1 specification will result in the following error codes listed in the EU eCTD validation criteria 7.1:

1.3ICH DTDA currently acceptable version of the DTD is used (checksum matches the published value)
4.3EU M1 leaf MOD fileThe checksum for the eu-leaf.mod file used must match the published checksum for the eu-leaf.mod file associated with the DTD used for the sequence
5.3EU M1 envelope MOD fileThe checksum for the eu-envelope.mod file used must match the published checksum for the eu-envelope.mod file associated with the DTD used for the sequence
6.3EU M1 stylesheetThe checksum for the style sheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence

Steps To Overcoming eCTD Validation Issues

Validating a sequence using the old specification will cause a validation failure as the checksums will not match the current standard.  If you validate your sequence and the following validation errors are listed relating to the checksum in the sequence not matching the standard, then you should follow the following suggestions to locate the issue.

  1. Go back to the validation software being used to revalidate the eCTD sequence and ensure it is up to date and validating to the current standard (i.e. EU eCTD validation criteria 7.1).
  2. Next, open the published sequence to confirm what DTD version was used. This information can be found in eu-regional xml file located with the module 1 folder.  At the top of this file a DTD version number can be seen above the EU envelope information.  Take this DTD version number and compare it to the DTD version number outlined in the current EU module 1 specification. Within this document will confirm the current DTD that should be used.  Besides, the current specification will outline the checksums for the eu-regional.dtd, eu-envelope.mod, eu-leaf.mod and eu-regional.xsl.
  3. If an out of date specification is being used, then your eCTD software may require an update to being in line with the current specifications.

eCTD Validation Error 1.4: ICH DTD

Explanation of Error Code:

If this error occurs, then the eCTD software being used to create the current sequence requires an update to bring the DTD/specification to a level that is equal to or higher than the previous sequence submitted.


In short, this error code can appear for several reasons.  For example, it can occur when dealing with multiple publishers operating using different versions of the eCTD software.  Therefore, it is important to ensure when an update to DTD/Specification is planned, that the update is done on all eCTD software in use simultaneously.  If this is not possible, then a strategic phased approach should be used to avoid sequences being published that used an older DTD/specification from the previous version published.

More of Your Questions Answered

This article is part of our ‘how-to’ and explainer series.  You can read over some of the most popular questions that we have answered by clicking to visit our ‘How-To’ and explainer section. Visit it here.

Do You Need Help with eCTD Issues?

We have a dedicated eCTD and electronic publishing team.  They can assist you with any of eCTD issues that you might be having.  Contact us by using the form below or by contacting us on 00353 52 61 76 706.

Further eCTD Reading

eCTD & Publishing Services

Many companies choose to outsource all of their eCTD & Electronic Publishing needs to our team, while others seek our assistance on a project by project basis.  Our expert team, headed by Eileen Ryan, has extensive experience of working on behalf of clients and managing their submissions to authorities around the world.  The publishing sector is experiencing significant change at present with, among other issues, the change to mandatory eCTD.  Our team can assist you in every aspect of your publishing needs.  Read more about our services here.

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services.

We typically encounter three scenarios:

  1. Companies that maintain control of electronic publishing at the corporate and head office level
  2. Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
  3. Companies that have outsourced eCTD entirely

Read more here.