Electronic submission of dossiers – CADDY-xml format

Date: 13 April 2020

In the “old days” of Regulatory Affairs, we used to ship truckloads (literally!) of paper dossiers to the authorities. Luckily, this has changed and we use CADDY.

CADDY (Computer Aided Dossier and Data Supply) which is an electronic format for the exchange and archiving of complex dossiers, developed jointly by industry and regulatory authorities. It is intended for the interchange of active substance and plant protection product dossiers, and is currently used by the European Commission and Member States as the only electronic dossier interchange format.

Since 1st of February 2014, the use of the CADDY-xml format is mandatory for the submission of plant protection product dossiers to the German authority (BVL). Other European authorities highly recommend using this electronic format. The CADDY-xml format is used for the preparation of new active substance dossiers (CA + CP), Annex I renewal (CA + CP) dossiers and product dossiers in dRR (draft Registration Report) format.

History

CADDY-xml is the optimised version of CADDY 2.0 format, and introduces some important differences by providing the general information, a table of contents, confidential and non-confidential documents and report information in an XML overview. The initial CADDY-xml Specification has been finalised in June 2005 and agreed in the Joint Caddy Steering Group.

The CADDY-xml Converter is the only authorised programme to convert CADDY 2.0 dossiers to the new standard CADDY-xml.

CADDY 2.0 is based on TIFF-files which are replaced in CADDY-xml by PDF and Word versions of the documents. Additionally, a CADDY-xml dossier can be viewed with a common web-browser supported by Acrobat Reader. It is flexible enough to accommodate different dossier structures or standard Tables of Content such as OECD, EU or others.

Future
GHSTS - The Global Harmonised Submission Transport Standard is considered as candidate to replace the current version of CADDY. Detailed information for GHSTS is announced for the summer of 2020.

Katharina Brüggemann