Primary source: EMA - What's new RSS
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Sign in to saveA public consultation period has been established for the draft revision of the VGVP Module on Signal Management. The start date is September 18, 2026, and the deadline for comments is December 18, 2026. The guidance includes a framework for various phases of signal management from detection to decision-making.
This revision of the VGVP is crucial for standardizing signal management processes across all organizations involved in veterinary pharmacovigilance. It aims to enhance the effectiveness of signal detection and management practices which are vital for ensuring the safety of veterinary medicinal products.
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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.
