Antimicrobial resistance in human medicine
Combatting the threat of antimicrobial resistance, particularly resistance to antibiotics, is a high priority for the European Medicines Agency (EMA) and the whole of the European medicines regulatory network. In human medicine, EMA focuses on promoting the prudent use of antimicrobial treatments, supporting the development of new antibiotics and encouraging new therapeutic options.
Antimicrobial resistance is when a microbe evolves to become more or fully resistant to antimicrobials which previously could treat it. Antimicrobials include antibiotics, which kill or inhibit the growth of bacteria. For more information, see Antimicrobial resistance.
In recent years, the availability of human medicines to treat infections with resistant organisms has become a major problem, due to the rapid emergence of drug resistant bacteria and the lack of new antibiotics entering the market. This is a major worldwide concern which threatens the effective treatment of infectious diseases.
Supporting the development of new antibiotics
A central pillar in EMA's strategy to fight antimicrobial resistance is to stimulate and facilitate the development of new antibiotics for use in humans.
EMA also works with international partners to align the data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments. For more information, see Antimicrobial resistance: overview.
In September 2015, the Agency released for public consultation a draft guideline on the use of pharmacokinetic and pharmacodynamic analyses in the development of antibiotics. The draft guideline provides guidance for medicine developers on how to conduct robust studies which could foster the development of new antibacterial agents including those that target multidrug resistant bacteria:
- Draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
In January 2012, the Agency updated its guideline for companies developing antibiotics on how they should carry out studies to test these medicines' benefits and risks. The guideline's addendum provides information on how to study medicines for specific indications:
- Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections
- Addendum on the note for guidance on the evaluation of medicinal products indicated for treatment of bacterial infections
In November 2013, the Agency hosted a workshop, co-organised with the European Commission, to discuss regulatory options for approval of new antibiotics and actions that could be taken to increase the appropriate use of current antibiotics:
- Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem (08/11/2013)
EMA published a joint report with the European Centre for Disease Prevention and Control (ECDC) and the international network ReAct - Action on Antibiotic Resistance in 2009 on the gap between infections due to resistant bacteria and the development of new antibiotics:
Encouraging new approaches
EMA supports the exploration of new therapeutic options for difficult-to-treat infections due to multidrug resistant bacteria.
In June 2015, EMA held a workshop on the therapeutic potential of bacteriophages, which are naturally occurring viruses that kill bacteria. Since their mechanism is completely different to that of antibiotics, bacteriophages could be effective against bacteria that have become resistant to antibiotics.
Based on the current EU regulatory framework, the Agency provided a platform to discuss fixed phage cocktails and is also taking steps to enable the development of such products. A written summary, video recording and meeting presentations are available:
In April 2016, EMA published a reflection on the therapeutic potential of bacteriophages in a scientific journal, highlighting the scientific and regulatory aspects discussed at the workshop.
Analysis of consumption and resistance
EMA works closely with the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) to analyse the potential relationship between the consumption of antimicrobials by humans and animals and the occurance of antimicrobial resistance. The EU agencies deliver their findings in joint inter-agency antimicrobial consumption and resistance analysis (JIACRA) reports.
The JIACRA reports analyse data from humans and food-producing animals from the agencies' five European Union (EU)-wide monitoring networks to better understand the occurrence of antimicrobial resistance across Europe and any trends occurring, providing valuable insights for policy-makers across the EU.
For more information, see Analysis of antimicrobial consumption and resistance (JIACRA reports).