Pest Management Regulatory Agency Experiences: Electronic

Chapter 27

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Pest Management Regulatory Agency Experiences: Electronic Submissions Carmen Krogh Health Canada, Pest Management Regulatory Agency, Room D746, Sir Charles Tupper Building, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, Canada

The Pest Management Regulatory Agency (PMRA) was created in 1995. The PMRA regulates all pesticides, (ie., products designed to manage, destroy, attract, or repel pests), that are used, sold, or imported into Canada.. It conducts science-based health risk, environmental risk, and value (including efficacy) assessments of each pesticide before determining if a pesticide product should be approved for use in Canada. By seeking to minimize the risks associated with pesticides, the PMRA helps protect human health, safety, and the environment.

The PMRA is committed to improving processes and to reducing costs associated with the review of submissions. The approach to meeting this commitment includes the application of process change management activities, international harmonization, and achieving an electronic capability through the application of technological solutions. These activities have formed the basis of the PMRA electronic submissions and review project. The project is international in nature with linkages established with the U.S. Environmental Protection Agency (EPA) - Office of Pesticide Programs (OPP), the European Union (EU),

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© 2002 American Chemical Society

Garner et al.; Capturing and Reporting Electronic Data ACS Symposium Series; American Chemical Society: Washington, DC, 2002.


217 the Organization for Economic Co-operation and Development (OECD), and the pesticide industry in Canada, the U.S., Australia, and Europe. The PMRA participates on the North American Free Trade Agreement (NAFTA) Technical Working Group (TWG),Regulatory Capacity Building sub-committee. Under this working group, PMRA and EPA are working with the North American pesticide industry to pilot joint projects in the electronic submission and review environment. This involves movingfrompaper-based processes to electronic ones.

Electronic Harmonization Currently, there are a number of harmonization activities in progress. Most of these involve harmonization of data and dossier formats and tend to be paper based. Harmonization efforts on work sharing are also currently underway among international regulatory authorities. Work sharing is facilitated by common formats for data submissions and review as well as electronic tools to make the submission assembly and review a more efficient and effective process. The benefits associated with an international harmonization approach include increased predictability and consistency of review time, a benefit to both industry and government. As well, harmonization of common formats allows evaluators to focus on the science of the reviews where less time is spent looking for information or reformatting information. With the use of electronic tools, evaluators can reuse information through 'copy and paste' techniques.

Submissions Process The submission process has three broad components and there has been positive progress in thefirsttwo: 1. Electronic assembly (involves the assembly of the electronic submission in a manner that evaluators can use); 2. Electronic evaluation (involves using the electronic submission for an electronic, desktop-based evaluation); and, 3. Electronic archiving (is needed by both industry and regulators).

Joint Industry-PMRA Pilot PMRA and Bayer, Inc., collaborated on an electronic submissions pilot project. Its purpose was to evaluate an electronic evaluation capability and to



218 prepare for the new way of doing business. The pilot format was designed to support the efficient electronic assembly and review of a submission. Required elements included the ability to deliver, store, update and retrieve information, and provide the PMRA evaluators with improved processes and functionality at the desktop. Bayer provided 4 submission formats: the Computer Aided Dossier, Delivery and Supply (CADDY) specification, the Portable Document Format (PDF) format, the PDF viewed in a web-browser, and paper. These formats were compared in a methodical and unbiased manner. It was determined that the PDF format gave evaluators a 23% gain in efficiency as compared to paper. Results clearly demonstrated that the PDF format provided evaluators with sufficient desktop functionality and improved efficiency. While CADDY is a useful tool for European industry and regulatory authorities, it was not embraced by PMRA evaluators because of its limitations as an aid to study review by regulatory staff

Electronic Submission Success Factors There are a number of factors that should be taken into consideration when developing electronic solutions. To be successful, the electronic solutions must support evaluator desktop needs and must utilize open standards / web-based tools to provide a neutral non proprietary approach that allows sharing of information internationally. The system must have the capacity to evolve, which dictates close co-operation between industry and regulators. Participants must be ready and prepared to deal with the change in data management requirements as well as work flow processes.

Guidance Available The PMRA has drafted 3 guidance documents to assist with the electronic submission process. These have been extensively commented on by industry and users in North America. 1. Guidance to Registrants for Preparing Electronic Submissions; Part II: Guidance for Industry During Pilot Stage. This document provides guidance to registrants on assembling an electronic submission. 2. Guidance to Registrants for Preparing Electronic Submissions; Part III: Guidance of Evaluator Functional Requirements for Electronic Evaluation. This document describes evaluator needs for e-review. 3. Guidance to Registrants for Preparing Electronic Submissions; Part IV:


219 Guidance on Preparation of Documents for Electronic Exchange. This provides guidance on how to create a document to minimize conversion issues between proprietary software such as Microsoft Word and Corel WordPerfect.


They are available on the PMRA web site: http:/www.hc-sc.gc.ca/pmra-arla

Evaluator Needs The PMRA evaluators determined their needs for conducting an efficient electronic review: 1. Navigation: ease in using bookmarks and links accessed by point and click. 2. Document Viewing/Printing: high quality, viewable on the screen, and (if needed) easy to print. 3. Document Annotation: must be able to add reviewer annotations. 4. Data Manipulation: ability to manipulate data using spreadsheet or other analytical methods. 5. Report Generation: ability to re-use information through copy and paste functionality. 6. Ergonomics: comfortable screen size, PC, and desktop design. 7. Links to other files: includes links to supplementalfilessuch as histograms, video.

Live Demonstration A joint demonstration of the electronic submission was presented jointly by representativesfromthe PMRA and Bayer, Inc.

Summary While the PDF format is not perfect, it meets the requirements for a 'neutral' format which is portable across the international pesticide community. The PDF based pilots are demonstrating positive results. Outcome expected from future pilots is establishment of an electronic submission formatting standard that strikes a good balance in meeting efficiency gains for both registrants and reviewers. The standard must be cost effective and easy for the wide range of North American registrants to implement. It must provide reviewers with easily learned functionality that makes their work more efficient and effective.


Pest Management Regulatory Agency Experiences: Electronic

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