A: 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. Please see the page
Specification
for more details.
A: The survey among CADDY users of the European
Regulatory Authorities has shown that further
improvements in the evaluation process are requested.
Wishes and suggestions to further improve the
evaluation-functionality of CADDY have been categorized
and decided upon at the Joint CADDY Steering Group
meeting in October 2000. The enhancements are included
in the new version 2.0 of the CADDY Format
Specification, e.g. CADDY Controlled Files and CADDY
hyperlinks.
A: All officially published versions of the CADDY Format Specification
(1.1, 2.0 and CADDY-xml) are valid. Nevertheless new
dossiers should be submitted in the most recent version
of the CADDY Format.
CADDY 1.1 and 2.0 format compliant dossiers remain
the European submission standard and will continue to be
supported.
This means that authorities can continue to use
already submitted CADDY 1.1 and CADDY 2.0 dossiers
without modification. Please use the CADDY-xml Converter
to convert existing CADDY 2.0 dossiers to the most
recent version of CADDY-xml.
While maintenance of the CADDY
Retrieval Software will continue, it is not planned to
develop further functionality.
It is expected that future work-sharing needs will
require more sophisticated review tools. The XML format
lays the foundation for such future developments.
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