The European Medicines Agency (EMA) published a revised draft reflection paper on 24 April 2026, updating its 2011 guidance on the use of macrolides, lincosamides, and streptogramins (MLS) in animals. The document, open for public consultation until 31 August 2026, highlights rising antimicrobial resistance (AMR) in pathogens such as Campylobacter coli and Brachyspira spp., and calls for optimised dosing, expanded monitoring, and better manure management to curb resistance under a One Health approach.
Document scope and regulatory context
The reflection paper reviews MLS pharmacological properties, use patterns, resistance development, and environmental impacts. It notes that macrolides and lincosamides are widely used in food-producing and companion animals, with sales showing a downward trend for lincosamides but fluctuations for macrolides between 2017 and 2024. The paper operates within existing EU regulatory frameworks: macrolides and lincosamides are classified as AMEG Category C (use with caution), and macrolides are listed as WHO Critically Important Antimicrobials.
Policy orientations and trade-offs
The EMA recommends several measures to mitigate AMR while preserving veterinary treatment options. These include: optimising dosing through pharmacokinetic/pharmacodynamic (PK/PD) studies (via the ADRA project), establishing veterinary-specific clinical breakpoints, educating veterinarians on manure management to reduce environmental residues, expanding AMR monitoring to include more MLS substances, investigating usage-resistance links, updating product information for third-generation macrolides, and supporting research on PK/PD, environmental resistance transmission, and clinical breakpoints.
These recommendations involve trade-offs. Stricter monitoring and dosing requirements could increase regulatory burden and costs for veterinary pharmaceutical companies and livestock farmers. However, they may also prolong the efficacy of MLS antibiotics, benefiting animal health and reducing the risk of resistant infections in humans. Environmental measures, such as improved manure management, may require additional investment from farmers but could reduce the spread of resistance genes in soil and water.
Impact on stakeholders
- Livestock farmers: May face higher costs from new dosing protocols, manure management practices, and potential restrictions on MLS use. However, better resistance management could reduce treatment failures and economic losses. - Veterinary pharmaceutical industry: Will need to invest in PK/PD studies and possibly reformulate products to meet updated breakpoints. This could increase R&D costs but also create opportunities for innovation. - Human health sector: Benefits from reduced AMR transmission via the food chain and environment, potentially lowering the burden of resistant infections in humans. - Environmental agencies and regulators: Will need to expand monitoring programmes and enforce new guidelines, requiring additional resources and coordination.
Expected institutional follow-up
Following the public consultation, the EMA will finalise the reflection paper, which may inform future revisions to EU guidelines on antimicrobial use in animals. The European Commission and Member States could use the findings to update AMEG categorisations or propose legislative changes under the EU's One Health Action Plan against AMR. The paper also supports ongoing research initiatives, such as the ADRA project, and may influence the European Parliament's discussions on sustainable veterinary medicine.
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