Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Scientific guideline

The guideline aims to provide guidance in respect to the data required to demonstrate the efficacy of veterinary medicinal products containing anticoccidial substances intended to be used in mammalian and avian target animal species.

Keywords: anticoccidial, antimicrobial, coccidia, coccidiosis, efficacy, oocysts

Current effective version

Guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/755916/2016 Legal effective date: 01/02/2026

Revision 1

Guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/755916/2016 Legal effective date: 01/02/2026

Overview of comments received on the Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (second version)

Reference Number: EMA/CVMP/EWP/58808/2025

Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (second version)

Draft: consultation closed Consultation dates: 18/10/2024 to 28/02/2025 Reference Number: EMA/CVMP/EWP/755916/2016 Summary:

This guideline will replace the current Guideline on anticoccidials used for the therapy of coccidiosis in8
chickens, turkeys and geese (7AE15a).

Comments should be provided using this template. The completed comments form should be sent to [e-mail]

Overview of comments received on the Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (first version)

Reference Number: EMA/CVMP/EWP/479402/2019

Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (first version)

Draft: consultation closed Consultation dates: 19/12/2018 to 31/08/2019 Reference Number: EMA/CVMP/EWP/755916/2016 Summary:

This guideline provides specific guidance in respect to the documentation required to demonstrate the efficacy of veterinary medicinal products (VMPs) generally developed for the prevention or reduction of clinical signs of coccidiosis, and the reduction of oocyst shedding. The previous NtA guideline on anticoccidial products (7AE15a) was limited to poultry. This guideline covers a wider range of mammalian and avian target species, containing now general data requirements for all target species, as well as specific requirements for poultry, ruminants, dogs and cats, pigs and rabbits.

First version

Guideline on anticoccidials used for the therapy of coccidiosis in chickens, turkey and geese

Adopted Reference Number: 7AE15a Volume 7 Legal effective date: 01/05/1993

Concept paper for the revision of the guideline on anticoccidials used for the therapy of coccidiosis in chickens, turkeys and geese (7AE15a; 1993)

Draft: consultation closed Consultation dates: 25/07/2016 to 31/10/2016 Reference Number: EMA/CVMP/EWP/706095/2015 Summary:

The guideline providing specific requirements with respect of the documentation of the efficacy of new veterinary medicinal products developed for therapy of coccidiosis came into effect in 1993. In 2014, a review of current CVMP guideline outlined in the ‘Draft concept paper on review and update of European Medicines Agency guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products’ (EMA/CHMP/CVMP/JEG-20 3Rs/704685/2012) took place.