The ICH Multi-disciplinary Group 2 (M2) Expert Working Group (EWG) is developing an XML-based specification governing electronic submission of pharmaceutical regulatory information. A version 1.0 XML DTD was completed in February 2002, along with the publication of a version 2.0 Electronic Common Technical Document (eCTD) specification. The eCTD is defined as "an interface for industry to Agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The focus of the specification is to provide the ability to transfer the registration application electronically from industry to a regulatory authority. Industry to industry and Agency to Agency transfer is not addressed... The specification for the eCTD is based upon content defined within the CTD issued by the ICH M4 EWG. The CTD describes the organization of modules, sections and documents. The structure and level of detail specified in the CTD has been used as the basis for defining the eCTD structure and content but where appropriate, additional details have been developed within the eCTD specification. The XML eCTD DTD (Document Type Definition) defines the overall structure of the submission."
Bibliographic information for the Version 2.0 specification: Electronic Common Technical Document Specification." From the ICH M2 Expert Working Group. Reference: ICH eCTD Specification V 2.0. February 12, 2002. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 'This specification has been developed by the ICH M2 Expert Working Group in accordance with the ICH Process as pertains to the M2 EWG.' 160 pages.
The XML DTD:
"The XML eCTD DTD (Document Type Definition) defines the overall structure of the submission. The purpose of the XML backbone is two-fold: (1) to manage meta-data for the entire submission and each document within the submission and (2) to constitute a comprehensive table of contents and provide corresponding navigation aids. Meta-data on submission level includes information about submitting and receiving organization, manufacturer, publisher, ID and kind of the submission, and related data items. Examples for meta-data on document level are versioning information, language, descriptive information such as document names, checksums, etc. Details are defined in appendix 6.
The XML instance of any submission should be created and validated according to the XML eCTD DTD as defined in appendix 8.
The XML eCTD DTD describes the hierarchical structure according to the CTD as defined by the ICH M4 expert working group. It includes multiple hierarchical levels depending on the specific module as defined in the CTD. The actual submission can include more hierarchical levels below those defined in the CTD. The XML eCTD instance covers the entire submission including all hierarchical levels and includes references to each individual file.
The submission should include a style sheet that supports presentation of the XML instance, navigation according to the table of contents and provides access to all documents within the submission. A standard style sheet is defined and provided by the ICH M2 EWG. Presentation and navigation via other style sheets on the receiving side should be possible.
The XML eCTD DTD includes a reference for each document to the physical file within the folder structure. The XML eCTD DTD includes attributes for descriptive names of folders and documents. [from the version 2.0 spec]
- FDA's eCTD website
- Electronic Common Technical Document Specification. Version 2.0. [cache]
- eCTD XML DTD Version 1.0. v0.96 renamed 1.0. February 6, 2002. [cache, alt URL]
- European Union website for eCTD
- ICH eCTD Specification V 2.0. EU website. February 12, 2002.
- EU Module 1 Specification. Module 1 of the electronic Common Technical Document (eCTD) for the European Union (EU). See the Draft version 0.72 of April, 2002 [cache]
- eCTD Template
- Electronic Application Form Specification. Draft July 12, 2002 or later. 16 pages. [cache]
- EU Module 1 Application Form DTD. Based on the Notice to Applicants, Volume 2B, Application Form, 18 June 2002 [cache]
- "Electronic Common Technical Document (eCTD) for Pharmaceuticals" - Main reference page