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). 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 |
[edit] 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 are defined by each of the ICH regions (USA, Europe and Japan).
[edit] IT point of view
[edit] 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.
[edit] 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.
[edit] Stylesheets
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.
[edit] 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.
[edit] 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.
[edit] 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).
[edit] References
- ^ "U.S. FDA Signals Intent to Reject eCTDs with Technical Issues". February 2, 2009. http://www.globalsubmit.com/home/LinkClick.aspx?fileticket=VtDTs2A/qZs=&tabid=37.
- ^ Kathie Clark (December 15, 2009). "Updates from the Regulators: FDA". The eCTD summit. http://theectdsummit.com/summit/?p=630.
- ^ Kathie Clark (June 30, 2009). "DIA Update: News from the FDA". The eCTD summit. http://theectdsummit.com/summit/?p=468.
[edit] External links
- ICH eCTD Specification V 3.2.2 (The specification)
- ICH M2 ESTRI Main
- Electronic Common Technical Document (eCTD) (FDA)
- EUDRALEX Volume 2 - Pharmaceutical Legislation : Notice to Applicants (EU legislation, contains section on eCTD)
- IT Pharma Validation Europe (Organization: CSV Validation Network)
- Exalon eCTD News - free and strictly neutral eCTD related news from regulators
- The eCTD summit blog
- eCTDBlog.com
- Regional file format requirements for eCTD
