From Wikipedia, the free encyclopedia
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).
Pharmaceutical point of view The eCTD has five modules
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/utilThe string ctd-123456/0000 is just an example.
Backbone (header)This is the file
index.xmlin the submission sequence number folder. For example:
ctd-123456/0000/index.xmlThe purpose of this file is twofold:
StylesheetsA stylesheet should be included that support the presentation and navigation. They must be placed in the directory:
ctd-123456/0000/util/styleSee entry 377 in Appendix 4.
DTDsDTDs must be placed in the directory:
ctd-123456/0000/util/dtdSee 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 <--- -->
AgencyThe lifecycle management is composed at least of:
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:
This article is based on an article from Wikipedia, the free encyclopedia and is available under the terms of GNU Free Documentation License.
In the Wikipedia there is a list with all authors of this article available.