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

Adopted Consultation dates: 28/06/2024 to 31/10/2024 Reference 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

Adopted Consultation dates: 28/06/2024 to 31/10/2024 Reference 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 closed Reference Number: EMA/CVMP/627/2001-Rev.2*

Revision 1

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

Adopted Reference Number: EMA/CVMP/627/2001 Rev.1 Summary:

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 closed Consultation dates: 04/03/2015 to 31/05/2015 Reference Number: EMA/CVMP/261180/2012 Summary:

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 closed Consultation dates: 29/05/2013 to 30/11/2013 Reference Number: EMA/CVMP/261180/2012 Summary:

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 closed Consultation dates: 07/04/2011 to 31/07/2011 Reference Number: EMA/CVMP/EWP/760764/2010

First version

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

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