Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats - Scientific guideline

This document provides special guidance on testing and evaluation of efficacy of veterinary antiparasitic products that are intended for external use for the treatment and prevention of tick and flea infestations, or systemic use for the treatment and prevention of flea infestations in dogs and cats. It also addresses the testing of veterinary antiparasitic products containing substances with insect growth regulating properties, either as mono-preparations or in combination with a flea adulticide. Read together with the Question and answers on the CVMP guideline on testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMEA/CVMP/005/00-Rev 2).

Keywords: Ectoparasitic veterinary medicinal product, tick, flea, dog, cat.

Current version

Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 4

Reference Number: EMEA/CVMP/EWP/005/2000 Rev.4Legal effective date: 28/01/2022

Document history

Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 3

AdoptedReference Number: EMEA/CVMP/EWP/005/2000 Rev. 3Summary:

This guideline is intended as an addition to the guideline on the “Demonstration of efficacy of ectoparasiticides” dealing with general requirements for the assessment of efficacy of such products. It provides specific guidance with respect to the testing and evaluation of efficacy of veterinary antiparasitic products for the treatment and prevention of tick and flea infestations in dogs and cats.

Overview of comments received on 'Draft guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 3'

Reference Number: EMA/CVMP/EWP/495905/2015Summary:

Overview of comments received on 'Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats' (EMEA/CVMP/EWP/005/2000 Rev. 3)

Draft guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 3

Draft: consultation closedConsultation dates: 20/03/2015 to 30/09/2015Reference Number: EMEA/CVMP/EWP/005/2000 - Rev.3Summary:

This guideline is intended as an addition to the guideline on the 'Demonstration of efficacy of ectoparasiticides' dealing with general requirements for the assessment of efficacy of such products.

Question and answers on the CVMP guideline on testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMEA/CVMP/005/00-Rev 2)

Reference Number: EMEA/CVMP/EWP/82829/2009 Rev. 2

Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 2

AdoptedReference Number: EMEA/CVMP/EWP/005/2000 Rev.2Legal effective date: 01/06/2002

Concept paper for the revision of the guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats - Revision 2

Reference Number: EMA/CVMP/EWP/290691/2012

Guideline for the testing and evaluation of the efficacy of antiparastic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 1

AdoptedReference Number: EMEA/CVMP/005/00-Rev 1Legal effective date: 09/05/2001

Overview of comments received on 'Draft guideline on the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats - Revision 1'

Reference Number: EMEA/CVMP/EWP/203830/2007