On 4 June 2026, the European Medicines Agency (EMA) published a standard operating procedure (SOP) detailing its contribution to the triennial JIACRA reports, which assess the link between antimicrobial consumption and antimicrobial resistance in humans, animals, and the environment. The SOP aims to streamline EMA's input to these joint inter-agency reports, which are produced together with the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA).
The document, issued by EMA's Veterinary Medicines Division, outlines the procedural steps for data collection, analysis, and submission. It specifies timelines, responsibilities, and quality control measures to ensure consistency across reporting cycles. The SOP applies to EMA's contribution to the JIACRA reports, which are mandated under EU legislation on antimicrobial resistance surveillance.
No prior coverage of this SOP exists in the public domain. The procedure formalises EMA's internal workflow for the JIACRA process, which has been ongoing since 2015. The most recent JIACRA report, published in 2024, highlighted a continued decrease in antimicrobial use in food-producing animals but stable or slightly increasing use in humans.
Impact on stakeholders
The SOP primarily affects EMA staff involved in antimicrobial resistance data analysis and reporting. It may also indirectly benefit national competent authorities and researchers who rely on JIACRA findings for policy-making. By standardising procedures, the SOP could improve the timeliness and reliability of EMA's contributions, supporting EU-wide efforts to combat antimicrobial resistance. However, the document does not introduce new regulatory requirements or targets, limiting its direct impact on pharmaceutical companies or healthcare providers.
Expected institutional follow-up
The SOP is effective immediately and will be reviewed periodically. EMA, ECDC, and EFSA are expected to continue their collaboration on the next JIACRA report, due in 2027. No further public consultation or revision is anticipated unless the underlying legal framework changes.
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