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

This document provide guidance on the statistical principles to be considered in the design, conduct, analysis and evaluation of clinical trials to demonstrate efficacy and/or safety of an investigational veterinary pharmaceutical product in animals.

Keywords: Antimicrobial, pharmacokinetic/pharmacodynamic (PK/PD) relationship, clinical study, summary of product characteristics (SPC), veterinary medicinal product (VMP)

Current effective version

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

AdoptedReference Number: EMA/CVMP/627/2001 Rev.1Summary:

This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product (VMP). Appropriate methods to identify and describe the pharmacology of the active substance in relation to the target bacteria are presented and important aspects to consider for justifying the use of a certain active substance for a particular indication are outlined.

Document history - Revision 1 (current version)

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

AdoptedReference Number: EMA/CVMP/627/2001 Rev.1Summary:

This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product (VMP). Appropriate methods to identify and describe the pharmacology of the active substance in relation to the target bacteria are presented and important aspects to consider for justifying the use of a certain active substance for a particular indication are outlined.

Overview of comments received on the draft revised guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

Reference Number: EMA/CVMP/EWP/374087/2015

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

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

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.

Overview of comments received on 'Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances’

Reference Number: EMA/CVMP/EWP/737951/2013

Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision

Consultation dates: 29/05/2013 to 30/11/2013Draft: consultation closedReference Number: EMA/CVMP/261180/2012Summary:

This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate methods to identify and describe the pharmacology of the active substance in relation to the target bacteria are presented and important aspects to consider for justifying the use of a certain active substance for a particular indication are outlined.

Concept paper on the revision of the CVMP guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

Consultation dates: 07/04/2011 to 31/07/2011Draft: consultation closedReference Number: EMA/CVMP/EWP/760764/2010

Document history - First version

Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - First version

AdoptedLegal effective date: 11/06/2003Reference Number: EMEA/CVMP/627/01