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 2

AdoptedConsultation dates: 28/06/2024 to 31/10/2024Reference Number: EMA/CVMP/627/2001 Rev.2*Summary:

This guideline provides recommendations for the design and conduct of pre-clinical studies and clinical trials for veterinary medicinal products containing antimicrobial substances. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.

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

 

Revision 2

Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 2

AdoptedConsultation dates: 28/06/2024 to 31/10/2024Reference Number: EMA/CVMP/627/2001 Rev.2*Summary:

This guideline provides recommendations for the design and conduct of pre-clinical studies and clinical trials for veterinary medicinal products containing antimicrobial substances. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.

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

 

Overview of comments received on 'Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances' (EMA/CVMP/627/2001-Rev.2)

Reference Number: EMA/CVMP/EWP/377613/2024

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

Draft: consultation closedReference Number: EMA/CVMP/627/2001-Rev.2*

Revision 1

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

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

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

Draft: consultation closedConsultation dates: 04/03/2015 to 31/05/2015Reference 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.

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

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

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

Draft: consultation closedConsultation dates: 29/05/2013 to 30/11/2013Reference 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

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

First version

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

AdoptedReference Number: EMEA/CVMP/627/01Legal effective date: 11/06/2003