CADDY-xml

1. Why?

The original CADDY format specification was developed in 1995 in order to provide an effective electronic transport medium for complete submissions from the applicant to the reviewer. At that point, study reports used for the preparation of submissions existed primarily in paper form in an archive or as paper scans in an electronic archive. The first CADDY specification was deliberately kept simple, to allow rapid implementation of a robust system. The original strategic goal was defined as follows:

To facilitate

• the provision of dossiers for pesticides to regulatory authorities,
• the long-term archiving of such dossiers
• the accessibility of information contained in such dossiers

in a cost-effective manner using electronic media.

These strategic objectives have been largely achieved in Europe, with electronic submissions in the CADDY format now the norm and the number of paper dossiers distributed to EU member states significantly reduced.

As a next step, an additional strategic objective of providing optimized support for the examination and assessment of dossiers by regulatory authorities was added. A driving force for the development of CADDY-xml has been the need to integrate the dossier submissions with the internal information systems of regulatory authorities.

Over the past 10 years, document management technologies have evolved considerably and XML-based web technologies have become standard. Applicants are increasingly storing study reports in native electronic formats (i.e. without scanning step). Also, additional electronic format - other than TIFF - suitable for long-term storage of documents have emerged and become ISO standards, such as PDF/A.

In spite of its success in replacing paper dossiers in Europe, the uptake of CADDY has been limited to agrochemicals in Europe, with other regions pursuing a different approach based on PDF. The CADDY standard, therefore, needs further development to make it useful as a tool for dossier and data exchange in the context of global work sharing, as it is currently being promoted by OECD. In addition, there is a clear trend towards more structured data submission based on OECD templates which needs to be appropriately supported by modern technology.

For this reason, the ECPA sSEG started work with the EU Commission and some EU member states to further explore a more flexible development of the CADDY standard.

2. What is CADDY-xml?

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 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.

Within this setup XML-representation can be thought of as the backbone of the dossier. It references every document that is included within the directory structure.

3. Current status

The initial CADDY-xml Specification has been finalized in June 2005 and agreed in the CADDY Forum. The CADDY-xml Converter is a conversion software that transforms CADDY dossiers into CADDY-xml dossiers. Both software and specification are available for download (CADDY-xml Specification / CADDY-xml Converter).

With these tools (specification and conversion software), applicants and reviewing authorities are able to create and exchange self-contained dossiers and a basis for further developments to support and facilitate work-sharing has been created.

4. Will CADDY 2.0 continue to be supported?

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. 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.

CADDY-xml presentation

You can download the presentation "CADDY-xml - Update on E-submissions in the European Union" which was presented by Mr. Meier-Manz to the OECD RSG Meeting in Wellington, New Zealand on December 2nd, 2005.
  Presentation "CADDY-xml - Update on E-submissions in the European Union" (135 KB; December 2nd, 2005)

• PDF/A: Portable Document Format for archiving and preserving documents, see http://www.aiim.org/pdf_a
• TIFF: Tagged Image File Format
• XML: Extensible Markup Language