CADDY-xml Format Specification and XSD

Format specification

The CADDY-xml Format Specification represents the core of the CADDY--xml standard.

XSD

The CADDY-xml XSD (XML schema definition) describes the XML backbone of a  CADDY-xml submission. Is is adapted when the ormat specification is changed in a way that implies changes to the XML backbone as well.

XSLT for static representation

Starting with specification version 03.08.00 the embedded viewer is no longer used and the eSubmission viewer is used for the display of CADDY-xml dossiers. To allow a quick content check of a dossier, the applicant has to supply an HTML file "caddy.html" in the root folder of the submission. This file can be generated with an XSLT file from caddy.xml, either by using the eSubmission viewer (see menu “File/Export rendition”) or by integrating the XSLT transformation in an inhouse publication process.

The required XSLT file is called "StandaloneHTMLView.xsl", is currently delivered as part of the eSubmission viewer and can be found in the Windows directory %AppData%\ECPA\eSubmissionViewer\xslt\caddy

Support lifecycle

New minor versions will be published if the changes are small and local, major versions are published when the changes are significant.

When a new minor version of the format specification is published then there will be a default transition period of one year until the predecessor version will become obsolete. For major version the transition period will be determined individually when the new major version is released.

History

The initial CADDY-xml Format Specification version 1.0.1 was released on July 19th, 2005. CADDY-xml is based on the CADDY 2.0 format, but introduces some important differences by providing the general information, a table of contents, confidential and non-confidential documents, report information and hyperlink information in an XML framework.

The TIFF-files used in CADDY V2 are replaced by PDF/A versions of the documents, which can be either image-based or text-based. Additionally, a CADDY-xml based dossier can be instantly viewed with a common web-browser supported by Acrobat Reader. This standard is flexible to accommodate different dossier structures such as OECD, EU or any other standard.