Industry Briefings

Re-categorisation of antimicrobials proposed by EMA’s AMEG

The European Medicines Agency (EMA) has released a consultation on its updated scientific advice on the categorisation of antibiotics. This new classification includes all classes of antimicrobials and comprises four categories from A to D, each with a key action word attributed for more clarity.

The EMA’s Antimicrobial Advice ad hoc Expert Group (AMEG) monitors and evaluates the risks of using antibiotics in animals.It is the only agency to examine this in light of antimicrobial resistance developments in animals, the possible transmission of resistance to humans, and the availability of alternative treatments to safeguard animal welfare.

This proposed reclassification is of significant importance to the UK as the Veterinary Medicines Directorate follows the EMA’s guidance, and does RUMA and its members (with the exception of a few species-specific modifications).

Under the new proposals:

  • Category A (“Avoid”) includes antimicrobial classes not currently authorised in veterinary medicine in the EU.
  • Category B (“Restrict”) refers to quinolones, 3rd- and 4th-generation cephalosporins and polymyxins (colistin). Use of these antimicrobials in animals should be restricted to mitigate the risk to public health.
  • The new Category C (“Caution”) covers antimicrobials for which, in general, alternatives in human medicine in the EU exist, but in veterinary medicine there are only few alternatives in certain indications. These antimicrobials should only be used when there are no antimicrobial substances in Category D that would be effective, and include Aminoglycosides, Aminopenciliins in combination with β-lactamase inhibitors, Lincosamides, Macrolides and Pleuromutilins.
  • Category D (“Prudence”) is the lowest risk category. Antimicrobials belonging to this category can be used in animals in a prudent manner.

The deadline for comments on these proposals is 30 April. The document including the draft advice can be accessed here and we also have a Summary of the draft EMA AMEG guidelines.

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