Regulatory Focus™ > News Articles > In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help

In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help

Posted 16 March 2015 | By Michael Mezher 

In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help

The European Medicines Agency (EMA) is looking for feedback on a new set of principles for setting the defined daily dose (DDDA) and defined course dose (DCDA) for antimicrobial products used in animals.

The guideline was drafted by the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) committee, and is intended to establish standards for setting DDDA and DCDA amounts for veterinary antimicrobial products. The consultation is part of an ongoing effort by EMA to combat antimicrobial resistance (AMR), which is linked to the overuse of antimicrobials in humans and animals.

The agency says using these measurements will improve its understanding of antimicrobial use and help measure the effects of its policies aimed at heading off AMR.


In September 2009, EMA launched ESVAC “to develop a harmonized approach for the collection and reporting of data on the use of antimicrobial agents” in animal populations. Specifically, ESVAC is intended to lead EMA in the following areas:

    1. “To aid interpretation of patterns and trends regarding antibacterial resistance;
    2. As a basis for risk profiling and risk assessment regarding antibacterial drug resistance;
    3. As a basis for setting risk management priorities;
    4. As a basis for evaluation of the effectiveness of control measures being implemented;
    5. To identify emerging use of antibacterial drugs, e.g. of specific drug classes such as critically important antibiotics;
    6. To aid comparison of usage of antibacterial drugs between and within countries and between time periods etc.;
    7. To assess the spread and effect of antibacterial drug pollution of the environment;
    8. As a basis for focused and targeted research and development.”

As part of its operations, ESVAC issues annual reports on the use of antimicrobials in Europe, the most recent of which found European antibiotic sales dropped by 15% between 2010 and 2012.

DDDA and DCDA as Reporting Standards

In 2013, ESVAC published a reflection paper that discussed data collection methods for antimicrobial consumption in different animal species and the technical units of measurement that are used to report that data. The reflection paper recommended using DDDA and DCDA instead of consumption by weight, arguing that these measures would provide improved data reporting on antimicrobial use and allow researchers to factor in variations in different species’ dosage requirements. ESVAC also says using these measures will make comparisons to data on antimicrobial use in humans more feasible.

Defined daily dose (DDD) for human medicines has been used for decades to make it easier to conduct drug comparison studies.

The Draft Guideline

The draft guideline is intended to establish principles for determining DDDA and DCDA for antimicrobial products for veterinary use.

The guideline defines DDDA as “the assumed average dose per kg animal per species per day” and DCDA as “the assumed average dose per kg animal per species per treatment course.” ESVAC says these values will be calculated using “average of all observations of veterinary medicinal products for each species, substance and administration route/form.” By assigning these values in kilogram per animal, ESVAC will be able to perform additional calculations across multiple animal weight groups.

The guideline was adopted by the ESVAC on 9 March 2015. ESVAC is asking for interested parties to submit their feedback by 13 May 2015.


ESVAC Public Consultation

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