The European Medicines Agency supports European Antibiotic Awareness Day, which is taking place on Sunday 18 November 2012.
European Antibiotic Awareness Day is an annual European public-health initiative that aims to raise awareness of the threat to public health and animal health of antibiotic resistance and the importance of prudent use of antibiotics.
New European Union-wide data released by the European Centre for Disease Prevention and Control (ECDC) to mark the day demonstrates that antibiotic resistance remains a major European and global public-health problem and is, for a large part, driven by the inappropriate use of antibiotics.
In the field of antibiotics, the European Medicines Agency’s main role is to evaluate applications for the authorisation of antibiotic medicines, both for humans and for animals, and to ensure that their conditions of use take the importance of following official recommendations on the appropriate use of antibacterial agents into consideration.
The Agency is concerned about the increasing levels of resistance to antibiotics in humans and animals and is engaged in a number of initiatives aiming to tackle this problem.
In 2012, the Agency has contributed to the global initiative to combat antibiotic resistance in the following areas:
- in January, the Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted an update to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. The guideline illustrates the overarching requirement for the development of antibacterial agents that have a direct action on bacteria resulting in inhibition of growth and replication;
- in July, the Agency released an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections for a six-month public consultation period. The addendum provides additional guidance on the requirements for clinical studies related to specific indications and on clinical development programmes for new antibacterial agents targeted at rare or multidrug-resistant pathogens. The period of public consultation for this guideline ends on 31 January 2013;
- in October, the Agency hosted a workshop on the development of new antibacterial medicines. The aim of the workshop was to discuss aspects of the development of antibiotic medicinal products, including those targeting multiple-drug-resistant pathogens. A summary report from the workshop is due for publication in early 2013;
- in October, the Agency also published its second report on sales of veterinary antimicrobial resistance from the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project. A total of 19 European Union (EU) and European Economic Area (EEA) countries submitted data on 2010 sales to the Agency. The 2012 report, as well as the report from 2011, will be used by risk assessors and risk managers in Member States to inform antimicrobial policy and responsible use of antimicrobials;
- in November, the Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) started a procedure to review all veterinary medicines containing enrofloxacin to be administered via drinking water to chickens or turkeys. The Committee will review the indications, dosages and withdrawal periods due to concerns related to antimicrobial resistance;
- throughout the year, the CVMP has continued to implement its strategy on antimicrobials 2011-2015.