To use all functions of this page, please activate cookies in your browser.
my.chemeurope.com
With an accout for my.chemeurope.com you can always see everything at a glance – and you can configure your own website and individual newsletter.
- My watch list
- My saved searches
- My saved topics
- My newsletter
Electronic Common Technical DocumentThe 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). Additional recommended knowledge
Pharmaceutical point of viewThe 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 is defined by each of the ICH regions (USA, Europe and Japan). IT point of vieweCTD (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 ctd-123456/0000/index.xml The 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/style See entry 377 in Appendix 4. DTDsDTDs 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:
Software ProductsAdditionally, a variety of software products exist to facilitate viewing and/or creating eCTD publications. Below is a partial list ordered by company names:
See also |
|
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Electronic_Common_Technical_Document". A list of authors is available in Wikipedia. |