Efficacy and Biological Assessment Dossiers (BADs)
Having effective data sets are vital for both the registration and renewal of plant protection products in Europe.
TSG’s efficacy team specializes in providing a full efficacy affairs service, from strategic advice and guidance to:
- Data gap analysis and GAP harmonization
- Study design and monitoring
- Dossier preparation and liaison with regulatory authorities
All types of plant protection products (including biopesticides, fungicides, herbicides insecticides, molluscicides) and biostimulants are covered.
TSG’s efficacy affairs service includes:
- Assessment of the quality of existing efficacy trial reports to ensure that they support the GAP table and that the data is suitable to be included in the Biological Assessment Dossier (BADs). The assessment can identify data gaps or potential problems at an early stage of the project, enabling TSG to advise clients on the next steps.
- Preparation of Biological Assessment Dossiers (BAD) and draft Registration Reports (dRRs, Part B, Section 3) for plant protection products according to Regulation (EC) 1107/2009.
- Consolidation of dossiers for re-registration of plant protection products including Art. 43 (EU) 1107/2009 registrations following active substance renewals.
- GAP (Good Agricultural Practices) harmonization. TSG can identify areas where existing uses can be harmonized, thereby simplifying the GAP. This potentially increases the number of suitable trials available and decreases the amount of data needing to be evaluated, saving clients both time and money.
- Management of multi-zonal projects with complex databases in accordance with existing national GAP tables. TSG can check available data packages, regardless of the size of EPPO zones and the number of regulatory jurisdictions.
- Efficacy study design and monitoring service to fulfil data requirements, including the preparation of trial programmes (e.g. treatment list, trial locations, included crops and pests), review of study plans and study reports, and data tracking and evaluation.
- Label preparation for plant protection products in accordance with CLP (Classification, Labelling and Packaging) Regulation.