Updated on 21 November 2025:
'Supporting development of new antibiotics' section - to include information on how the EMA's Emergency Task Force (ETF) supports medicine developers
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 happens when a microbe evolves to become more or fully resistant to antimicrobials which could previously treat it.
Antimicrobials include antibiotics, which kill or inhibit the growth of bacteria.
In recent years, the availability of human medicines to treat infections with resistant organisms has become a major problem. This is 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.
For more information, see:
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.
As of March 2025, EMA’s Emergency Task Force (ETF) supports all developers of medicines and novel approaches for the treatment and prevention of bacterial and fungal infections caused by resistant pathogens. This includes tuberculosis.
The ETF can provide free-of-charge preliminary discussions to medicine developers. This helps developers become aware of and use formal regulatory tools such as EMA’s scientific advice.
EMA encourages developers to contact the ETF secretariat at any stage during medicine development at: PHEearlyinteractions@ema.europa.eu.
Developers of new antibiotics can benefit from parallel scientific advice on their development plans from EMA and the Unites States Food and Drug Administration (FDA).
For more information, see:
Guidance on the use of pharmacokinetic and pharmacodynamic analyses in the development of antibiotics is available below.
This aims to guide medicine developers on how to conduct robust studies which could foster the development of new antibacterial agents including those that target multidrug resistant bacteria:
Guidance is available for medicine developers on how they should design their clinical studies to demonstrate the benefits and risks of antibiotics.
This guideline 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:
Guidance is also available on how to demonstrate the medicine's benefit-risk balance in children, in an addendum to the guideline.
Find the guidance below:
EMA hosted a workshop to discuss regulatory options for approval of new antibiotics and actions that could be taken to increase the appropriate use of current antibiotics.
EMA co-organised this workshop with the European Commission.
We also published a joint report with the European Centre for Disease Prevention and Control (ECDC) and the international network ReAct - Action on Antibiotic Resistance on the gap between infections due to resistant bacteria and the development of new antibiotics.
In addition, we work with international partners to align data requirements for certain aspects of the clinical development of new antibiotics. This is in order to stimulate the development of new treatments.
For more information, see:
EMA supports the exploration of new therapeutic options for difficult-to-treat infections due to multidrug resistant bacteria.
We held a workshop on the therapeutic potential of bacteriophages. These 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, EMA provided a platform to discuss fixed phage cocktails and is also taking steps to enable the development of such products. A written summary and meeting presentations are available via the workshop link below.
EMA also published a reflection on the therapeutic potential of bacteriophages in the Journal of Antimicrobial Chemotherapy. This reflection highlighted the scientific and regulatory aspects discussed at the workshop.
For more information, see:
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: