Date of Publication: 20-Feb-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency (EMA) has released Revision 3 of its guideline on risk management requirements for elemental impurities in veterinary medicinal products. This update reflects the evolving regulatory expectations for controlling elemental impurities and reinforces the importance of science-based risk assessment and control strategies to ensure the quality, safety, and consistency of veterinary medicines.
Elemental impurities, which may arise from manufacturing processes, raw materials, equipment, or environmental sources, pose potential risks to animal health and, indirectly, to human health through the food chain. This revision aligns veterinary regulatory expectations more closely with internationally harmonized principles, including those established by the International Council for Harmonisation (ICH), particularly risk-based approaches similar to ICH Q3D principles used in human medicines.
The revised guideline emphasizes a structured risk management framework. Marketing authorisation holders and applicants are expected to conduct comprehensive risk assessments considering all potential sources of elemental impurities, including active substances, excipients, manufacturing equipment, and container closure systems. Where risks are identified, appropriate control measures—such as process controls, supplier qualification, or analytical testing—must be implemented and justified.
Importantly, the guideline clarifies expectations for documentation and lifecycle management. Companies must maintain robust scientific justification for their risk assessments and ensure ongoing monitoring throughout the product lifecycle. This includes reassessing risks when there are changes in manufacturing processes, raw material suppliers, or product composition.
From an industry perspective, this revision strengthens regulatory expectations around proactive risk identification and mitigation. Pharmaceutical companies involved in veterinary medicinal product development and manufacturing must ensure their quality systems are capable of identifying and controlling elemental impurities using a science-based and risk-proportionate approach. This may require updating existing risk assessments, reviewing supplier controls, and enhancing documentation practices to remain compliant with EMA expectations.
This update also supports regulatory convergence and promotes consistent quality standards across veterinary medicinal products within the European Union. Ultimately, the revision contributes to improved product safety, regulatory transparency, and confidence in veterinary medicines used across the EU.
KEYWORDS: Risk Management, Impurity Assessment, Regulatory Standards
REFERENCE: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-risk-management-requirements-elemental-impurities-veterinary-medicinal-products-revision-3_en.pdf https://www.ema.europa.eu/en/risk-management-requirements-elemental-impurities-veterinary-medicinal-products-scientific-guideline