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). As of January 1, 2008, the U.S. Food and Drug Administration announced that the eCTD is the preferred format for electronic submissions.[1] To date, over 98,000 eCTD sequences have been submitted to the FDA.[2] Although the agency has not released an expected target date, the FDA revealed during the 2009 DIA Annual Meeting that it is looking at draft legislation to require eCTD.[3]
Contents |
The eCTD has five modules
A full table of contents could be quite large.
There are two categories of modules:
The CTD only defines the content of the common modules. The contents of the Regional Module 1 are defined by each of the ICH regions (USA, Europe and Japan).
The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The primary technical components are:
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.
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:
Stylesheets 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 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.
The business process to be supported can be described as follows:
Industry <-----> Message <-----> Agency
The lifecycle management is composed at least of: