What is CADDY?

What is CADDY? CADDY is a concept that provides all necessary information and tools for industry to allow preparation of "CADDY-conform" electronic dossiers, and for regulatory authorities to review these dossiers.

The basis of CADDY is the format specification. This specification, currently version 2.0, is a technical document that describes how a dossier should be stored on electronic media, e.g. CD-ROM. The format specification allows software developers to create CADDY compilation software, software that allows regulatory staff to prepare an electronic CADDY dossier, either by scanning paper documents, or by retrieving them from existing in-house electronic archiving systems. Compilation software is at this moment already commercially available, as well as compilation services by specialized consultants. CADDY also provides a freely available conformity test software, which allows the user to verify that his compiled CADDY dossiers are compliant with the format specification. To allow a better integration with the internal information systems of regulatory authorities and to provide the ability of viewing dossiers without installing additional software, the CADDY-xml format specification version 1.0.1 was published in July 2005.

A typical CADDY dossier consists of a set of 2-4 CD-ROMs: one or more CDs containing the pages of the "paper dossier", one containing "confidential pages", and one containing index-information.

CADDY also provides a CADDY Application Guide, providing instructions for industry staff on how to best prepare their dossiers, in order to facilitate the evaluation process for regulatory authorities.

Finally, CADDY provides the CADDY retrieval software. This software provides access to CADDY dossiers, allowing the user to search, view and print those regulatory documents he is looking for. Industry and Regulatory Authority users of the retrieval software need a support-contract, which gives them access to the helpdesk, error reception, Updates i.e. minor releases, bug fixing, and an unlimited number of seats to install the CADDY RSW including the embedded Recognita OCR software. Since the beginning of 2001, this retrieval software and the necessary support are freely available for regulatory authorities and companies.

In addition to the viewing and printing features, the CADDY retrieval software provides several features that facilitate the review process: hyperlinks can be set to allow quick navigation within a dossier, but can also be placed in review documents or in electronic communications, allowing direct access to relevant pages in a dossier; annotations can be exported and imported, allowing work sharing between authorities, Caddy Controlled Files allow integration of different file-types in a dossier (e.g. PDF, Word, XML, etc.).

In 2000, CADDY was already commonly used in Europe for the submission and review of new substances. However, CADDY also plays an important role in the European review program where in addition to new submissions a large number of dossiers for existing substances have been submitted in the CADDY format. Early 2001, the Standing Committee on Plant Health decided that submission of electronic dossiers (CADDY only) should be encouraged for the review program.