Antimicrobial resistance – European Medicines Agency releases draft advice on the impact on public health and animal health of the use of antibiotics in animals

News 01/08/2014

The European Medicines Agency (EMA) has published PDF icondraft recommendations today in response to a request from the European Commission related to the impact on public health and animal health of the use of antibiotics in animals.

The European Commission made this four-part request for advice in April 2013 as part of its action plan against the rising threats from antimicrobial resistance (AMR). The emergence and steady increase in the occurrence of bacteria that are resistant to multiple antibiotics has become a global public-health threat due to the lack of therapeutic options to treat certain infections in man.

The first question from the European Commission related to the use in animals of 'old' antibiotics or new antibiotics belonging to 'old' classes of antibiotics that have been re-introduced or have a new use to treat multidrug-resistant infections. The question focused in particular on colistin and tigecycline, two antibiotics that have become life-saving treatments for patients infected by multidrug-resistant bacteria. The response to this question was provided to the Commission and published on the EMA website in July 2013.

The three remaining questions relate to:

  • the merits or otherwise of classifying antimicrobials considered as critically important by the World health Organization for use in man ('critically important antimicrobials', CIAs) 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 by WHO as critically important for use in man.

The draft makes a number of recommendations, such as the strengthening the AMR risk assessment as part of the evaluation of marketing authorisation applications for new antimicrobials, particularly those intended for use in food producing species; improved reporting of the extent and evolution of the 'off label' use in animals of antimicrobials that are authorised in man for use against multi-drug resistant infections; and the need for risk profiling of certain classes of antibiotics with respect to their use in animals for which this has not yet been done. All of these recommendations are intended to minimise the risk of transmission of resistance from animals to humans.

These draft recommendations have been released for public consultation until 30 September 2014. Comments should be sent to

For the preparation of its advice, the EMA has sought the views of all the experts across the European Union on the development and use of antimicrobials. These experts, who formed the Antimicrobial Advice Ad Hoc Expert Group (AMEG), include representatives from the EMA's Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Medicinal Products for Human Use (CHMP) as well as the CVMP Antimicrobials Working Party and the CHMP Infectious Diseases Working Party, the European Food Safety Authority (EFSA), the European Centre for Disease Prevention and Control (ECDC) and the Joint Interagency Antimicrobial Consumption and Resistance Analysis Report (JIACRA).

The draft advice produced by the AMEG on the second, third and fourth questions of the Commission was endorsed by both the CVMP and CHMP at their respective meetings in July 2014.

The final response to this four-part request is expected to be finalised by the end of 2014.

As part of the preparation of its advice, the EMA conducted an initial consultation exercise in February 2014 in order to give to its stakeholders an opportunity to provide information and data and share their views on the requests from the European Commission. PDF iconComments received as part of this exercise have been published today.

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