Primary source: Pharmacovigilance (veterinary medicines)
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Sign in to saveThe EMA introduced new guidance regarding pharmacovigilance requirements for centrally authorised veterinary medicinal products for 2026. This includes monthly updates on the products affected and necessary compliance steps as outlined in the recommendations.
The updated guidance affects regulatory compliance and pharmacovigilance practices across all sponsors and marketing authorisation holders of veterinary medicinal products within the EU, ensuring that they meet the latest standards set by the EMA.
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PV teams should update workflows and SOPs to include the new section 19A approval processes and ensure compliance with the TGA's guidelines for managing medicine shortages.
PV teams should update their workflows regarding inspection readiness, review standard operating procedures (SOPs) to align with the new GCP inspection coordination processes, and ensure that all relevant personnel are trained on the updated guidance.
PV teams should review and update their Standard Operating Procedures (SOPs) related to real-world data collection methodologies and ensure alignment with the new guidance emerging from the workshop. Training may also be required to enhance understanding of RWD's impact on regulatory submissions.
PV teams should update their regulatory intelligence monitoring workflows to include the timelines and requirements established by the EMA for thalassaemia treatments. It's essential to ensure adherence to the new guidelines in clinical trial designs.
