Current State of Electronic Submissions in Europe - ACS Symposium

Chapter 26

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Current State of Electronic Submissions in Europe Steven C. Dobson Pesticides Safety Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York Y08 8QA, United Kingdom

The CADDY (Computer Aided Dossier Design and Supply) system has been developed as a practical, flexible and efficient platform for the electronic submission of regulatory dossiers. The CADDY system is in use within the European Union (EU). This paper provides information on the principles behind the development of CADDY; the benefits of CADDY to both industry and regulators; the current status of CADDY adoption, focussing primarily on EU Member States; and future developments.

Introduction The driving force for the development of a standardized format for electronic submission of regulatory dossiers for agrochemicals in Europe dates back to 1993. In that year, European Council Directive91/414/EEC(1) came into force and provided a harmonized basis for the regulation of plant protection products across the 15 Member States of the European Union (EU). As part of that legislation, a program for the re-evaluation of all active substances on the European market was established. Several hundred active

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substances were to be included in this program, which was envisaged to be completed within 10 years. In 1995,the first list of 90 active substances was identified for re-evaluation, and industry was required to submit dossiers for these substances in a standard format. The same format also applied to applications for new active substances. At the start of the program it became obvious that compiling, transporting and handling these paper-based dossiers imposed a considerable burden, in terms of costs and staff time, on both industry and regulatory authorities. EU dossier submissions contain up to 100,000 pages, the majority of which comprise the individual regulatory studies. In addition, a structured and detailed overview is also supplied by industry (often as word processor/spreadsheet files) as well as additional supporting documentation. Also, in several Member States more than one copy of the full dossier is required, resulting in over 30 copies of the dossier having to be prepared and shipped to support one active substance. Against this background, Member States faced the need to find ever increasing storage space to cope with paperbased dossiers submitted to support both existing and new active substances.

Development of an Electronic Submission Format To address these difficulties, a working group, formed of delegates from the European Commission, EU Member States, and European industry [represented by the European Crop Protection Association (ECPA)]firstmet in 1995 to discuss proposals for the development of a standard format for electronic dossier submissions. This group became the EU Member States/ECPA Data Transfer Steering Group (the CADDY group) and the system that they developed became known by the acronym CADDY (Computer Aided Dossier and Data Supply). By early 1996, the CADDY group had identified an initial strategic goal for the CADDY system which was to facilitate, in a cost-effective manner, using electronic media: 1. the provision of dossiers for plant protection products to regulatory authorities; 2. the long-term archiving of such dossiers, and; 3. the accessibility of information contained in such dossiers. The CADDY group determined that the system should have a flexible transfer interface that served the individual needs and requirements of end users. In addition, the system should be modular, capable of incorporating and


211 integrating new technology and adapting to changing regulatory needs. The C A D D Y specifications were built around the following objectives, that: 1.


2.

3. 4. 5.

6.

the first release should be very simple and cover only those requirements that were absolutely necessary; the page format (stored dossier pages) and index file format (the indexing system necessary to provide efficient document/information retrieval) should be readable by a wide range of standard applications; the retrieval software should meet the needs of users and allow a C A D D Y submission to replace a paper copy, i f desired; the storage and transfer medium should be C D - R O M , so that a complete dossier could be submitted on 2-3 discs; all the pages of the dossier should be represented as TIFF (Tag Image File Format), which are readable by a wide range of standard imaging applications; and the index information should be represented in a format readable by standard database applications.

From the outset, it was considered that a system that met these objectives would be sufficiently flexible to offer a potential basis for world-wide harmonization of electronic submissions. Thus, in the autumn of 1996, the C A D D Y Group was expanded to form the Joint Data Transfer Steering Group to include representatives from the US Environmental Protection Agency (EPA), the American Crop Protection Association (ACPA), the Canadian Pest Management Regulatory Agency (PMRA), and Canadian industry representatives. The specifications for C A D D Y were actively developed by this expanded group, and the requirements of the North American participants were incorporated into both the format and retrieval specifications. Against this background the specification and components of the system were completed. The main components of the system are shown in Table I. The retrieval software was developed to allow rapid access to the dossier information and to meet the initial needs of users in both industry and Regulatory Agencies. The range of functions available to the regulatory evaluator when working with an electronic submission is an important factor in determining its successful adoption. Therefore, the functions implemented in the C A D D Y retrieval software provide the evaluator with the ability to: •

display/print dossier details.

•

access studies via either a hierarchical and expandable table of contents or a study (report) list.

•

bookmark studies.


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•


• • • • •

annotate studies with private (evaluator only) or public (all users) comments. conduct bookmarks and annotation searches. select and sort studies by using a comprehensive multi-attribute search tool. print study lists and details, print studies and study pages. navigate studies using a 'toolbox' (goto next/previous page;first/lastpage; page orientation/zoom; goto by page number). select text/figures from studies and use optical character recognition to export selections to word processor/spreadsheet files.

Table I. Components of the CADDY System Format specification Compilation software Conformity test software Retrieval software Information brochure Application guide

Defines the format for compiling a CADDY submission. First versionfinalizedin January 1996. Current version 1.1, finalized September 23, 1997. Freely available. Compiles a CADDY submission. The development of the software necessary to compile a CADDY-compliant submission, in line with the format specification, is the responsibility of industry/commercial organizations. Reports if a dossier on CD-ROM conforms to the CADDY format specification. Current version Revision 18, April 20, 1998. Freely available. Allows the submission to be displayed and worked with by Regulatory Agencies and others. First versionfinalizedin February 1997. Current format specification 1.2 (version 1.0) August 1999. Software and support available at nominal cost. Provides an overview of the CADDY project. Current version dated March 1998. Describes how to deal with CADDY and what to expect from a CADDY submission. Current version dated April 22,1998 (2).

Adoption of CADDY Within Europe and Initial Experiences By the end of 1997 the first release of the retrieval software completed the components of the CADDY system and allowed the initial strategic goal of the CADDY group to be achieved, which was to provide a practical and workable electronic submission system. To date, 53 organizations worldwide (43 in



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Europe, 8 in North America and 1 each in Japan and India) have purchased licenses for the retrieval software and help desk support, covering a total of 563 licenses. Organizations range from regulatory authorities, research based manufacturers, generic manufacturers to consultancy/contract houses. The system has also been demonstrated to a wide range of interested organizations involved in pesticide regulation, including authorities considering biocides in the EU; the Food and Agriculture Organization in Rome; the World Health Organization in Geneva; regulatory authorities in Central and Eastern Europe; as well as the Organization for Economic Co-operation and Development's Working Group on Pesticides. CADDY has been adopted as the standard for electronic dossier submissions for plant protection products within the European Union. For example, since the release of the retrieval software in 1997, the UK has received a total 15 CADDY submissions, with similar numbers having been received by other Member States. The system has led to improved efficiency in dossier compilation by industry and significant savings in handling and shipping costs. On this basis companies have been quick to realize the benefits of electronic dossier assembly. Production of electronic submissions in CADDY format from in-house document management systems, such as Documentum, has reduced the time to assemble dossiers and associated costs. Novartis estimated that a recent EU CADDY submission, comprising 8 paper copies and 32 CADDY dossier copies, represented a saving of over $100,000 compared with paper-based dossiers alone. For regulatory authorities in Europe, the adoption of CADDY has provided a means of alleviating the burden of handling and storing paper based submissions. Initial experience with the CADDY system has involved its use as an aid to dossier completeness checking and as a tool for rapid access to underlying studies in support of decision making. So far the use of CADDY based submissions for evaluation has focussed on discrete parts of the regulatory submission, for example, physical chemical properties and methods of analysis. While initial feed back from users in Regulatory Agencies has been positive, CADDY, like other electronic submission methods, is unlikely to replace fully the need for paper submissions in the medium-term. Important ergonomie issues remain to be resolved before full evaluations of active substance dossiers routinely will be conducted electronically, and a true paperless submission process is achieved. In particular, a general handicap of electronic submissions is the readability of the text on the screens. The resolution and size of screens remains a limiting factor for the computer based evaluation process. This is not a CADDY specific issue but is applicable to all types of electronic submission, as today's screen technology is still not comparable to paper in terms of readability or ease of use for prolonged periods.


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As a first step toward this goal of a true paperless submission, the potential exists to use CADDY as a replacement for paper when evaluating limited data packages, such as those supporting product registrations.


Future Development of CADDY In 1999, to address the needs of regulators and industry to fully utilize CADDY as an evaluation tool, the CADDY Group revised the strategic goal to include 'the examination and assessment of dossiers by regulatory authorities'. This acknowledged the desire of the regulators and industry to enhance and develop the potential of CADDY as an evaluation tool. As part of this process, the retrieval software was further enhanced with the release of an 32 bit version with improved functionality and network support. In order to assess the requirements for the further development of the retrieval software, industry members of the CADDY group examined the current use of CADDY in 6 European regulatory authorities early in 2000. The analysis found that overall there was significant interest in CADDY but only evaluators in the larger authorities had actual experience with the software. While the current CADDY functionality was judged by evaluators in the 6 countries to be sufficient for their immediate needs, further improvements were identified. Therefore, to increase the use and acceptance of the CADDY retrieval software, the following measures have been identified for action: 1. Improve functionality - in the next stage of development the addition of hyperlinks between summaries and reports, improved copy, pasting of tabular data, and full text search will be considered. In late 1999, the Steering Group adopted a future vision for CADDY that included additional elements coded using XML (extensible Markup Language) to enhance functionality with structured data and provide a basis for longterm development; 2. Improve online help and establish an e-mail hotline; 3. Provide updated documentation and training material with every new version; 4. Improve user support and decrease response time with in-house or offsite training; 5. Visit authorities regularly to promote and assess the adoption of CADDY; 6. Update the CADDY website with new areas like discussion groups and FAQ's; and


215 7. Improve industry quality control systems to ensure high quality CADDY dossiers are submitted that fully comply with the format specification.


Conclusion The adoption of CADDY within the EU has provided a sound basis for the transfer of regulatory dossiers between industry and regulators. CADDY has been developedfrominception to a workable system in 5 years and represents a significant collaborative effort between industry and regulators drawn from North America as well as Europe. This initial achievement, has resulted in substantial reductions in compiling, transporting and handling costs for EU dossiers and has provided a basis for rapid dossier access. CADDY is now being further developed to build upon and enhance its capabilitiesforuse as an evaluation tool. Further information on CADDY is available on the ECPA website (www.ecpa.be).

References 1. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, O.J. No L 230, 19.8.1991. 2. Guidelines for preparation of dossiers by applicants. Doc 1663/VI94 Rev 8 of 22.4.1998.


Current State of Electronic Submissions in Europe - ACS Symposium

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