The guidelines include recommendations that aim to reduce the risk of development of antimicrobial resistance in animals and to prevent transmission of resistance to humans
The European Medicines Agency (EMA) has released for public consultation two guidelines related to the assessment of antimicrobials for use in veterinary medicine.
The first guideline, drafted by the EMA's Committee for Medicinal Products for Veterinary Use (CVMP), focuses on the assessment of the risk to public health resulting from the use of antimicrobial substances in food-producing animals.
As part of an application for marketing authorisation for antimicrobial veterinary medicines the risk of transmission of resistance to humans through food or through direct contact with livestock should be assessed. The draft guideline outlines a systematic approach for the assessment of the risks and provides advice on the required data and methodology to be used by medicine developers. The guideline is applicable to antimicrobial products that have not been previously authorised for use in food-producing animals, as well as to applications where the new authorisation can lead to increased use of antimicrobial products or to an increased risk to public health.
Stakeholders are invited to send their comments on this draft guideline before 31 August 2015.
The second guideline is a revised CVMP guideline for the demonstration of efficacy for veterinary medicines containing antimicrobial substances. The current guideline first came into effect in June 2003.
The revision aims to provide guidance on the development of new veterinary antimicrobials while taking into account the risk of development of antimicrobial resistance and the need to promote the responsible use of these substances.
The revised guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy of antimicrobial veterinary medicines. The document presents methods to identify and describe the pharmacology of active substances in preclinical studies and outlines important aspects on the use of a certain substance for a particular indication.
The public had been consulted on a first revision of this guideline already in 2013. This was followed by a focus group meeting with stakeholders to discuss certain aspects of the proposed revisions and to address concerns raised during the consultation phase.
This second revision provides further information on the use of veterinary antimicrobials in animals that are at risk of being infected (methaphylactic use). The document also clarifies the study requirements for antimicrobials that should be reserved for certain situations only.
Stakeholders are invited to send their comments on this draft guideline by 31 May 2015.
Comments on both guidelines should be sent to ve[email protected] using the forms provided.