AVANT: developing alternatives to veterinary antimicrobials in the European Union regulatory context

Summary

The aim of the European Union Innovation Action ‘Alternatives to Veterinary Antimicrobials’, known as AVANT, was to develop new, targeted, non-antibiotic alternatives for the control of post-weaning diarrhoea in pigs. The project focused on four types of alternatives: gut microbiota modulators to maintain a healthy microbiome, therapies targeting the pathogen (enterotoxic Escherichia coli), immunostimulants and feeding strategies (dietary formulations). Up to now, limited regulatory guidance and support for the development and authorisation of alternatives to antimicrobials have been established. The lack of guidance leads to uncertainties in how to progress towards a marketing authorisation in the European Union, either as a veterinary medicinal product or as a feed additive.

This article reviews the regulatory framework for seven specific, mostly orally administered alternatives to antibiotics: synbiotics (combinations of probiotics and prebiotics), faecal microbiota transplantation (FMT)/faecal filtrate transplantation (FFT), bacteriophages, polymers, immunostimulants (oral and injectable) and feeding strategies. The potential legal classification of these interventions is evaluated, together with the data requirements for authorisation in the European Union. A particular focus is placed on FMT/FFT, which have shown promising results in reducing diarrhoea prevalence. Several hurdles need to be addressed to facilitate applications for marketing authorisations/registrations, as applicable. The development of innovative, non-antibiotic interventions in livestock production is a societal priority that requires legislative support. The article concludes with a set of pragmatic strategies to facilitate the registration and use of such interventions.

Keywords

Alternatives – Antimicrobials – Authorisation – Feed additives – Innovative interventions – Pigs – Post-weaning diarrhoea – Regulatory – Veterinary medicinal product.