A Data Gap Analysis (DGA) for the registration of plant protection products (PPPs) is a structured review that identifies what scientific or regulatory data are missing, incomplete, outdated, or non-compliant with current requirements. It is an essential step when preparing a new registration dossier or updating an existing one for pesticides, biopesticides, or other crop protection products.
A Data Gap Analysis evaluates the available studies and documentation for a plant protection product against the current regulatory data requirements of the jurisdiction where registration is sought (e.g., EU Regulation (EC) 1107/2009, CIPAC methods, OECD guidelines, etc.).
Its purpose is to ensure that all necessary scientific evidence is present to demonstrate the product’s safety, efficacy, and quality.
Objectives of a PPP Data Gap Analysis
- Determine completeness of existing data
Check whether all study areas required by regulation are covered. - Assess compliance of existing studies
Are studies performed under the right test guidelines (e.g., OECD)?
Are they GLP-compliant when needed?
Are they still valid or outdated due to evolving regulations? - Identify missing, invalid, or insufficient studies
Highlight mandatory studies that must be generated. - Support regulatory strategies
Plan timelines, budgets, and decisions on whether the product can be registered or renewed. - Mitigate risk
Reduce chances of regulatory rejection or further requests for information.
Output of a PPP Data Gap Analysis
A DGA typically results in a structured report, including:
Summary of existing studies Gap list (missing or non-compliant studies) Justifications for waivers (where scientifically valid) Proposed strategy and timeline for generating missing data Estimated costs and regulatory milestones