To facilitate the newly established Directive
91/414/EEC procedure for (re-)registration of plant
protection products ECPA, the EU Commission and the
European Member States agreed in 1995 to jointly develop
an electronic standard for the submission of plant
protection dossiers in Europe under the acronym "CADDY".
The "Joint EU Member States / ECPA Data Transfer
Steering Group" consisting of five experts from European
Member States, a representative from the EU Commission
and five experts from ECPA was established in June 1995
to work out a solution to meet their strategic goals:
To facilitate
- the provision of dossiers for
pesticides to regulatory authorities,
- the long-term archiving of such
dossiers,
- and the accessibility of
information contained in such dossiers in a
cost-effective manner using electronic media.
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 and
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 eSEG started
work with the EU Commission and some EU member
states to further explore a more flexible development of
the CADDY standard.
The initial
CADDY-xml Specification has been finalized in
June 2005 and agreed in the
Joint Caddy Steering Group. 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 /
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.