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). On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs). To date, more than 600,000 eCTD sequences have been submitted to the FDA.

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 defines the content only of the common modules. The contents of the Regional Module 1 are 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:

• A high level folder structure (required)
• An XML "backbone" file which provides metadata about content files and lifecycle instructions for the receiving system
• An optional lower level folder structure (recommended folder names are provided in Appendix 4 of the eCTD specification)
• Associated document type definitions (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

Stylesheets that support the presentation and navigation should be included. 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 entries 371–76 in Appendix 4. They must follow a naming convention.

The DTD of the backbone is in Appendix 8. It must be placed 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.

See also

• Clinical trial
• Clinical Data Interchange Standards Consortium
• European Medicines Agency (EMA)
• Food and Drug Administration (FDA)
• Ministry of Health, Labour and Welfare (Japan).
• Russian Ministry of Healthcare and Social Development (Russia).

External links

• Electronic Common Technical Document (eCTD) (FDA)

Submissions Management]