Regulatory Focus™ > News Articles > EMA Concept Paper Calls for Guideline on Antimicrobial Resistance Assessments

EMA Concept Paper Calls for Guideline on Antimicrobial Resistance Assessments

Posted 23 January 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has released a new concept paper on the need for a new guideline to better quantify and control the risks of antimicrobial resistance stemming from veterinary antimicrobial products.

Antimicrobial Resistance

The concept paper, for a guideline on microbial resistance risk assessment, makes the case that antimicrobial resistance (AMR) is an increasingly important problem for both regulators and public health officials, and that the proper use of veterinary medicines plays a key role in stemming the increase of AMR bacteria.

EMA notes that humans can come into contact with AMR bacteria through contact with the animals or through foodborne exposure. This, paired with the fact that a limited number of new antimicrobial products have come to market in recent years, have regulators highly concerned.

But none of this is particular new-regulators and public health officials from around the world have been noting this problem for decades, calling upon prescribers and industry to use existing antimicrobials more judiciously to guard against the emergence of new AMRS.

What is new-at least for the EU-would be a more systematic qualitative risk assessment related to the potential for the use of a product to cause antimicrobial resistance. These risks are currently evaluated in a number of ways, but those assessments fall short in a number of areas, regulators explained. In particular, they aren't able to assess the product's off-label use, does not take into account the huge number of unknown factors involved in risk quantification, and does not adequately take into account that existing AMRs might become even more resistant after the introduction of a new drug.

A New Guideline

But perhaps the biggest hurdle is one that regulators say they can solve: the lack of a guideline detailing data requirements for the exposure assessment.

The concept paper lists three different aspects that EMA wishes to take under consideration in the future:

  • "The amount/likelihood of resistant bacteria of certain strains present in the gastrointestinal-tract of the treated individual."
  • "Pre-harvest at group level: The number of animals treated and the rate of spread of resistant bacteria between animals."
  • "Post-harvest: Procedures during and after slaughter, including processing, retail and kitchen handling will have impact on the overall exposure to humans. However, these are factors that are fully independent of the use of any antimicrobial in animals and therefore they could only be considered in a general schematic way."

Regulators wrote that companies might also suggest risk mitigation measures to minimize the risk of improper prescribing, such as by adding warnings or contraindications to the summary of product characteristics or narrowing the target population.

If the concept paper is adopted, EMA would likely release the guideline in spring 2013, it said. Comments on the proposal are due by 30 April 2013.


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