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)
-
List item
Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 1 (PDF/219.92 KB)
Adopted
First published: 03/02/2016
Last updated: 03/02/2016
EMA/CVMP/627/2001 Rev.1 -
List item
Overview of comments received on the draft revised guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (PDF/350.07 KB)
First published: 03/02/2016
Last updated: 03/02/2016
EMA/CVMP/EWP/374087/2015 -
List item
Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (PDF/244.96 KB)
Draft: consultation closed
First published: 19/12/2018
Consultation dates: 19/12/2018 to 31/08/2019
EMA/CVMP/EWP/755916/2016 -
List item
Overview of comments received on 'Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances’ (PDF/532.15 KB)
First published: 04/03/2015
Last updated: 04/03/2015
EMA/CVMP/EWP/737951/2013 -
List item
Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision (PDF/220.56 KB)
Draft: consultation closed
First published: 29/05/2013
Last updated: 29/05/2013
Consultation dates: 29/05/2013 to 30/11/2013
EMA/CVMP/261180/2012 -
List item
Concept paper on the revision of the CVMP guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (PDF/79.25 KB)
Draft: consultation closed
First published: 20/04/2011
Last updated: 20/04/2011
Consultation dates: 07/04/2011 to 31/07/2011
EMA/CVMP/EWP/760764/2010
- Efficacy: pharmaceuticals
- Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics
- Focus group meeting on the revision of the CVMP guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (09/12/2013)
- Regulation (EU) 2019/6
-
Summary of product characteristics for veterinary medicinal products containing antimicrobial substances
-
Question and answer on the CVMP guideline on the SPC for antimicrobial products
-
Use of fluoroquinolones in food producing animals - precautions for use in the SPC regarding prudent use guidance
- Directive 2010/63/EC
- Good Laboratory Practice
- Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals conduct of efficacy studies for intramammary products for use in cattle
- Conduct of pharmacokinetic studies in target animal species
- Fixed combination products
- Statistical principles for veterinary clinical trials
- VICH GL9 Good clinical practices
- VICH GL27 Guidance on the pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance