Advice on impacts of using antimicrobials in animals

The European Medicines Agency (EMA) is involved in monitoring and evaluating the risks of using antibiotics in animals. It has looked in particular at the risk of the development of antimicrobial resistance in animals and of the possible transmission of resistance to humans.

EMA is supporting the European Commission's One Health Action Plan against Antimicrobial Resistance.

The European Commission requested scientific advice from EMA in April 2013 on the impact on public health and animal health of using antibiotics in animals and measures to manage the possible risk to humans. The request was structured in the form of four questions:

Use of 'old' antibiotics

The Commission's first question concerned the use in animals of 'old' antibiotics or new antibiotics belonging to 'old' classes of antibiotics that have been re-introduced or newly used to treat multidrug-resistant infections, with a particular focus on colistin and tigecycline, two antibiotics that have become life-saving treatments for patients infected by multidrug-resistant bacteria.

In response, EMA's Antimicrobial Advice Ad Hoc Expert Group (AMEG) concluded that:

  • maintaining the use of colistin in animals was approproate, with additional monitoring of off-label use and restrictions on indications to therapy or metaphylaxis and removing all indications for prophylactic use in order to minimise any potential risk associated with a broader use;
  • glycylcycline use in animals should remain restricted, due to evidence from human use that tigecycline resistance emerges rapidly.

For more information, see:

Revised advice on colistin

In 2016 AMEG revised its 2013 advice on the use of colistin in animals on request of the European Commission, following the discovery of a gene (called mcr-1) that causes bacteria to become resistant to colistin.

The updated recommendation advises that:

  • European Union (EU) Member States should minimise sales of colistin for use in animals, to achieve a 65% reduction in EU-wide sales;
  • colistin be added to a more critical category of medicines, reserved for treating clinical conditions for which there are no effective alternative treatments.

EMA published its updated advice in July 2016, after the CVMP and CHMP endorsed the AMEG opinion. This advice took account of a public consultation and an open call for scientific data.

For more information, see:

Advice on classification, authorisation and risk mitigation

The Commission's second, third and fourth questions concerned:

  • the merits or otherwise of classifying antimicrobials considered critically important for humans into different categories with respect to their recommended use in animals;
  • the potential impact of authorising new antimicrobials or classes of antimicrobials, for use in animals on the treatment of resistant bacteria in humans;
  • risk mitigation measures for antimicrobials that are already authorised for use in veterinary medicine and are considered as critically important for humans.

EMA published its response in December 2014, following endorsement by the CVMP and CHMP and input from a public consultation. EMA's advice included:

  • strengthening antimicrobial resistance risk assessment in the evaluation of marketing-authorisation applications for new antimicrobials, particularly if intended for use in food-producing animals;
  • improved reporting on 'off label' use in animals of antimicrobials authorised in humans for use against multi-drug resistant infections;
  • further risk profiling of certain classes of antibiotics with respect to their use in animals.

For more information, see:

Categorisation and preliminary risk profiling of new antimicrobials

In July 2017, the European Commission requested EMA to update the AMEG categorisation of antimicrobials and to further elaborate on the proposed preliminary risk profiling of new antimicrobials (previously known as 'early hazard characterisation').

For more information, see:

Published: EMA published the finalised PDF iconscientific advice of AMEG on the preliminary risk profiling for new antimicrobial veterinary medicinal product It provides advice at an early stage in the development of antimicrobial veterinary medicines on the potential public health risks derived from antimicrobial resistance.

Update: The PDF iconupdated scientific advice of AMEG on the categorisation of antimicrobials is expected to be finalised until the end of 2019. It includes new classes of antibiotics, additional categorisation criteria and the availability of alternative antimicrobials in veterinary medicine.

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