Efficacy addresses the question, “Does the product do what the label says it will do?” Submission of efficacy data to support plant protection and biocide product registrations is a requirement for many countries around the globe. Efficacy data must be summarised systematically, in an acceptable format, to enable the regulatory authority to evaluate it effectively.
The Biological Assessment Dossier (BAD)
Directive 91/414/EEC, as amended by Directive 93/71/EC, contains all the efficacy data points that must be addressed to support a product registration within the EU. All data must be summarised in a BAD, reflecting the proposed use. BAD formats vary among EU Member States.
Efficacy is also a requirement for Annex I inclusion of biocidal active substances in the EU. Tiered summary reports are required for both the active substance and the product. Following Annex I inclusion of the active substance, EU Member States require the submission of a detailed efficacy dossier to support the product.
Our efficacy staff have the experience to write BADs for plant protection products, and for biocides, both the tiered summaries and product efficacy dossiers, to meet all the EU Member State requirements.
Additional services we offer include:
- Data gap analysis of your current efficacy data set (identifying concerns and providing possible solutions)
- Planning efficacy tests to fulfil the necessary data requirements (to best fit with desired timelines for submission to regulatory authorities)
- Development of test protocols that reflect appropriate guidance documents (i.e., EPPO, FAO, WHO, ISO, EPA, OECD)
- Guidance in placing efficacy tests with the most suitable testing facilities (having both the necessary certification and expertise to undertake such tests)
- Manage efficacy testing programmes (including study monitoring and data collation)
- Drafting of product labels
- Expert assistance in representing your needs in meetings with regulatory authorities
- Expert audits of efficacy testing facilities
- Expert advice to efficacy testing facilities on setting up systems to meet GEP requirements