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.
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.
Early dialogue with developers
As of 24 May 2019, EMA's Innovation Task Force (ITF) is open to all developers of medicines and therapeutic approaches for the treatment or prevention of life-threatening or debilitating bacterial and fungal infections. This free-of-charge service provides medicine developers a forum for early dialogue with EMA and help their orientation and subsequent use of formal regulatory tools such as EMA’s scientific advice.
EMA encourages developers to contact the ITF secretariat at any stage during medicine development.
Use of pharmacokinetic and pharmacodynamic analyses
Guidance is available on the use of pharmacokinetic and pharmacodynamic analyses in the development of antibiotics in the guideline linked below. This 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:
- Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products - Scientific guideline
Demonstrating benefit-risk balance
Guidance is available for medicine developers on how they should design their clinical studies to demonstrate the benefits and risks of antibiotics:
- Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline
The current revision of the guideline, published in May 2022, reflects the joint efforts of EMA, the FDA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to align their data requirements as much as possible. The aim of this is to help medicine developers design clinical trials that meet the requirements of multiple regulatory agencies.
The revision also provides guidance in the following areas:
- Recommended development programmes for antimicrobials intended to address an unmet medical need
- Clinical trial designs to use for specific indications, including uncomplicated urinary tract infections and uncomplicated gonorrhoea
- Displaying microbiological and clinical efficacy data in the summary of product characteristics
Guidance is also available on how to demonstrate the medicine's benefit-risk balance in children, in an addendum to the guideline. EMA published this addendum in May 2022:
- Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - Scientific guideline
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:
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.
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.
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 occurrence 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).