Data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats - Scientific guideline
Table of contents
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
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Guideline on data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats (PDF/422.33 KB)
Adopted
First published: 24/06/2022
Legal effective date: 01/01/2023
EMA/CVMP/EWP/278031/2015 -
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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) (PDF/364.95 KB)
First published: 24/06/2022
EMA/CVMP/EWP/552708/2018
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Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector- borne diseases in dogs and cats (PDF/181.1 KB)
Draft: consultation closed
First published: 27/07/2018
Last updated: 27/07/2018
Consultation dates: 27/07/2018 to 31/08/2019
EMA/CVMP/EWP/278031/2015 -
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Concept paper for a guideline on data requirements regarding veterinary medicinal products for the prevention of transmission of canine and feline vector-borne diseases (PDF/81.29 KB)
Draft: consultation closed
First published: 18/11/2014
Last updated: 18/11/2014
Consultation dates: 18/11/2014 to 28/02/2015
EMA/CVMP/EWP/309734/2014