Data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats - Scientific guideline

This guideline provides recommendations for the design and conduct of studies to support the efficacy of veterinary medicinal products (VMPs) intended for the reduction of the risk of transmission of vector-borne pathogens (VBPs) in dogs and cats, which can be transferred by blood-feeding arthropods. The guideline outlines the requirements for pre-clinical studies and clinical trials.

Keywords: Vector-borne disease (VBD), vector-borne pathogen (VBP), blood-feeding arthropods, reduction of the risk of transmission of VBPs, efficacy, veterinary medicinal product (VMP), ectoparasiticides, repellent effect, dog, cat

Current version

Guideline on data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats

AdoptedReference Number: EMA/CVMP/EWP/278031/2015Legal effective date: 01/01/2023

Overview of comments received on the ‘Guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector-borne diseases in dogs and cats’ (EMA/CVMP/EWP/278031/2015)

Reference Number: EMA/CVMP/EWP/552708/2018

Document history - First version

Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector- borne diseases in dogs and cats

Draft: consultation closedConsultation dates: 27/07/2018 to 31/08/2019Reference Number: EMA/CVMP/EWP/278031/2015

Concept paper for a guideline on data requirements regarding veterinary medicinal products for the prevention of transmission of canine and feline vector-borne diseases

Draft: consultation closedConsultation dates: 18/11/2014 to 28/02/2015Reference Number: EMA/CVMP/EWP/309734/2014Summary:

Vectors are living organisms - such as diptera (mosquitoes, sand flies, muscid flies), ticks, fleas and lice - that transmit a disease from an infected animal to a human or another animal. Vector-borne diseases (VBDs) are caused by a wide range of infectious agents including viruses, bacteria and parasites (protozoa and helminths). VBDs may be highly pathogenic in dogs and cats, and diseased animals may have persistent infections and act as reservoirs for several zoonoses (leishmaniosis, Lyme disease, bartonellosis etc.). The threat of VBDs may increase based on a combination of factors like changing social and economic conditions, globalised travel and trade, increased urbanisation, climatic changes, environmental and ecosystem changes.