Electronic Common Technical Document

The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format.

It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).

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Pharmaceutical point of view

The eCTD has five modules

• 1 Administrative Information and Prescribing Information
• 2 Common Technical Document Summaries
• 3 Quality
• 4 Nonclinical Study Reports
• 5 Clinical Study Reports

A full table of contents could be quite large.

There are two categories of modules:

• Regional module: 1 (different for each region; i.e., country)
• Common modules: 2-5 (common to all the regions)

The CTD only defines the content of the common modules. The contents of the Regional Module 1 is defined by each of the ICH regions (USA, Europe and Japan).

IT point of view

eCTD (data structure)

The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The primary technical components are: 1) a high level folder structure (required); 2) an XML "backbone" file which provides metadata about content files and lifecycle instructions for the receiving system; 3) an optional lower level folder structure (recommended folder names are provided in Appendix 4 of the eCTD specification); 4) associated DTDs and stylesheets. Each submission message constitutes one "sequence". A cumulative eCTD consists of one or more sequences. While a single sequence may be viewed with web browser and the ICH stylesheet provided, viewing a cumulative eCTD requires specialized eCTD viewers.

The top part of the directory structure is as follows:

ctd-123456/0000/index.xml
ctd-123456/0000/index-md5.txt
ctd-123456/0000/m1
ctd-123456/0000/m2
ctd-123456/0000/m3
ctd-123456/0000/m4
ctd-123456/0000/m5
ctd-123456/0000/util

The string ctd-123456/0000 is just an example.

Backbone (header)

This is the file index.xml in the submission sequence number folder. For example:

ctd-123456/0000/index.xml

The purpose of this file is twofold:

• Manage meta-data for the entire submission
• Constitute a comprehensive table of contents and provide corresponding navigation aid.

Stylesheets

A stylesheet should be included that support the presentation and navigation. They must be placed in the directory:

ctd-123456/0000/util/style

See entry 377 in Appendix 4.

DTDs

DTDs must be placed in the directory:

ctd-123456/0000/util/dtd

See entry 371 to 376 in Appendix 4. They must follow a naming convention.

The DTD of the backbone is in Appendix 8. It must be place in the above directory.

Business process (protocol)

The business process to be supported can be described as follows:

 Industry <-----> Message <-----> Agency

The lifecycle management is composed at least of:

• Initial submission: should be self-contained.
• Incremental updates: with its sequence number.

Software Products

Additionally, a variety of software products exist to facilitate viewing and/or creating eCTD publications. Below is a partial list ordered by company names:

• Datafarm eCTDBuilder
• docuBridge (multiple electronic formats: eCTD/CTD, eNDA, PDF, RPS ready etc. and paper) Submission Management System builder/viewer/validator/publisher
• DoubleBridge ROSETTA eCTD suite
• DoubleBridge ROSETTA phoenix - eCTD Viewer (Free Download)
• DoubleBridge ROSETTA sceptre - Full lifecycle Validator
• DoubleBridge ROSETTA scribe - eCTD Builder/Publisher
• DoubleBridge ROSETTA pyramid - Active Archive for eCTD and paper submissions
• eCTDer (freeware) - no longer developed
• eCTDmanager - Extedo/IABG-LSS eCTD builder/viewer/validator/publisher (electronic and paper) all in one
• eCTDtemplates(tm) - Extedo/IABG-LSS eCTDtemplates(tm) for Authoring eCTD content
• EURS is Yours(tm) - Extedo/IABG-LSS Review and Validation of eCTD submissions. EMEA uses EXTEDO/IABG-LSS EURS is Yours
• GECCO - eCTD Viewer/Validator - for US/EU/CA - FREE DOWNLOAD
• http://www.globalsubmit.com/ - GlobalSubmit Review and Validate - FDA uses GlobalSubmit Review and Validate
• i4i's ALiCE eCTD Manager

• IBM Solution for Compliance in a Regulated Environment (IBM SCORE)
• ISI eCTDXPress
• Liquent Insight Publisher
• MedXView eCTDcomposer
• Mission3 OnDemand Product Lifecycle Management
• Octagon's ViewPoint(R)
• Octagon's ViewPoint eCTD Complete
• Octagon's StartingPoint(R) Global eCTD Authoring Templates
• A Suite of Knowledge Management Solution - eCTD Submission, DMS, SOP version Control and Distribution, SPL
• TAKE's PharmaReady eCTD Submission Management Suite

See also

• Clinical trial
• Clinical Data Interchange Standards Consortium
• European Medicines Agency (EMEA)
• Food and Drug Administration (FDA)
• Ministry of Health, Labour and Welfare (Japan).