EMA Proposes New Monitoring for Macrolides and Lincosamides to Combat Antimicrobial Resistance
The European Medicines Agency (EMA) is taking a decisive step to curb the rise of antimicrobial resistance (AMR) in animals. The EMA’s committee for veterinary medicines has adopted a new draft reflection paper focused on the use of macrolides, lincosamides and streptogramins—collectively known as MLS—within the European Union.
This move aims to update previous guidelines from 2011, reflecting the latest scientific understanding of how these substances impact both animal health and public safety. The draft is currently open for public consultation until August 30, 2026, inviting stakeholders to help shape the future of veterinary antimicrobial stewardship.
Understanding MLS: What Are These Antimicrobials?
To understand why the EMA is grouping these drugs together, it’s important to look at how they work. While they are different classes of drugs, they share common resistance mechanisms, meaning bacteria that develop a defense against one may become resistant to the others.
- Macrolides and Lincosamides: These are widely authorized and used in both human and veterinary medicine. They are essential for treating bacterial infections, particularly those affecting soft tissues and the respiratory tract, in both livestock and companion animals.
- Streptogramins: Unlike the others, streptogramins are not authorized for veterinary use in the EU and are rarely used in human medicine. However, they are included in this review because of their shared resistance pathways with macrolides and lincosamides.
The Path to Better Monitoring: The Role of EFSA
A central pillar of the EMA’s proposal is the need for more rigorous surveillance. The draft suggests that the European Food Safety Authority (EFSA) should officially include macrolides and lincosamides in its monitoring panel for antimicrobial resistance in food and livestock.
By integrating these substances into regular monitoring, health authorities can achieve several critical goals:
- Early Detection: Identifying emerging trends in resistance before they become widespread.
- Tracking Diffusion: Monitoring how resistant bacteria and antimicrobial resistance genes spread through animal populations.
- Targeting Zoonotic Pathogens: Specifically tracking dangerous pathogens that can jump from animals to humans, such as Escherichia coli, Salmonella spp., Campylobacter spp., and Enterococcus spp.
Risk Management and Future Research
Beyond monitoring, the draft reflection paper provides a comprehensive review of the pharmacological properties and usage patterns of these drugs across the EU. It explicitly identifies gaps in current knowledge and highlights the need for risk management measures to protect both animals and the environment.
By pinpointing these knowledge gaps, the EMA is setting the stage for targeted research to ensure that these vital medicines remain effective for years to come.
How to Participate in the Consultation
The EMA is actively seeking feedback on this proposal to ensure the final guidelines are practical and effective. Interested parties can submit their comments until August 30, 2026.
To participate, the Committee has provided a standardized template for submissions. Comments should be sent via email to awpsecretariat@ema.europa.eu.
Key Takeaways
- New Guidelines: The EMA is updating its 2011 reflection paper on the use of MLS antimicrobials in animals.
- Broad Scope: The review covers macrolides and lincosamides (common in vet use) and streptogramins (rarely used/not authorized in EU vet use).
- EFSA Integration: The EMA recommends that EFSA monitor these drugs in livestock and food to catch resistance trends early.
- Public Health Focus: A major goal is limiting the spread of zoonotic pathogens like Salmonella and E. Coli.
- Deadline: The window for public comment closes on August 30, 2026.
Frequently Asked Questions
Why are streptogramins included if they aren’t used in EU veterinary medicine?
They are included because they share similar resistance mechanisms with macrolides and lincosamides. Studying them as a group provides a more complete picture of how bacteria develop resistance to this entire family of antimicrobials.
What are zoonotic pathogens?
Zoonotic pathogens are bacteria, viruses, or parasites that can be transmitted from animals to humans. Examples mentioned in the EMA draft include Salmonella and Campylobacter.
Why is this update necessary now?
The previous reflection paper was published in 2011. Given the rapid evolution of antimicrobial resistance and new data on pharmacological impacts, an update is required to protect both animal welfare and human public health.