The European Medicines Agency (EMA) has unveiled Revision 17 of its guidelines under the Committee for Veterinary Medicinal Products, scheduled to become effective on October 1, 2025. This revision concentrates on the application of the Veterinary Dictionary for Drug Related Affairs (VeDDRA) terminology, aiming to streamline and harmonize the reporting process for suspected adverse events in both animals and humans.
Key Changes in VeDDRA Terminology
Revision 17 introduces a four-level hierarchical structure within VeDDRA, encompassing System Organ Class (SOC), High Level Term (HLT), Preferred Term (PT), and Low Level Term (LLT). This structure ensures precise classification of adverse events, facilitating more accurate data analysis. Notably, the revision emphasizes selecting LLT level terms that accurately reflect the clinical signs, thereby enhancing the reliability of PT and SOC groupings during analysis.
Implications for Veterinary Practices
Veterinary professionals and pharmacovigilance teams must adapt to these updates by familiarizing themselves with the new terminology and coding guidelines. The revision addresses various clinical scenarios, including death reporting, hypersensitivity reactions, and local reactions, providing clear instructions on appropriate term selection. This ensures consistency and validity in adverse event reports, crucial for monitoring the safety and efficacy of veterinary medicinal products.
– Enhanced clarity in reporting reduces the risk of misclassification of adverse events.
– Standardized terminology facilitates better data comparison across different regions and studies.
– Improved reporting accuracy supports regulatory decision-making and public safety initiatives.
Adopting these revised guidelines will require comprehensive training and updates to existing reporting systems within veterinary practices. Stakeholders are encouraged to review the detailed guidance notes provided by EMA to ensure seamless integration of the new terminology into their pharmacovigilance workflows.
Veterinary practitioners play a pivotal role in the early detection and reporting of adverse events. By adhering to the updated VeDDRA criteria, they contribute to a robust surveillance system that safeguards animal health and enhances the overall quality of veterinary medicinal products. The EMA’s proactive approach underscores its commitment to maintaining high standards in pharmacovigilance.
Implementing these changes not only aligns with regulatory expectations but also fosters a culture of precision and accountability within the veterinary community. As the landscape of veterinary medicine evolves, such updates are essential in addressing emerging challenges and ensuring the continued safety of medicinal products.
EMA’s Revision 17 marks a significant advancement in adverse event reporting mechanisms. Veterinary professionals should prioritize understanding and applying these new guidelines to enhance the accuracy and effectiveness of their reporting practices. This proactive adaptation will ultimately lead to improved animal welfare and more reliable medicinal product assessments.
Staying informed about regulatory changes and actively participating in training sessions will be crucial for veterinary teams. Embracing the updated VeDDRA terminology facilitates better communication, data consistency, and regulatory compliance, thereby strengthening the overall pharmacovigilance framework within the European Union.
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