The Business Case for the Joint Evaluation of Dossiers (Data Submissions) Using Work-Sharing Arrangements

In 2004, OECD countries agreed to a ten-year vision for the harmonisation of regulatory approaches for agricultural pesticides (chemical and biological) to facilitate and promote the sharing of work between regulatory authorities. The highlight of this “Vision” is that by 2014, OECD countries will routinely accept dossiers prepared by stakeholders in the OECD format; will routinely exchange "monographs" containing reviews of the data submitted; and will use OECD "monographs" as a basis for independent risk assessments and regulatory decisions for new and existing pesticides. This document describes the benefits that will accrue to regulatory authorities, companies (registrants) and the general public as a result of joint evaluations of dossiers.