The European Medicines Agency (EMA) announced significant revisions to the VeDDRA list of clinical terms, essential for reporting adverse events related to veterinary medicinal products. This update, effective from June 2025, introduces numerous additions, deletions, and modifications to enhance the clarity and precision of adverse event reporting for both animals and humans.
Key Changes
The updated VeDDRA list encompasses 153 specific changes, addressing various system organ classes such as behavioral, blood and lymphatic, cardiovascular, digestive, and more. Notable modifications include the renaming of terms to better reflect clinical conditions, the addition of new terms like “serosal discharge,” and the removal of outdated entries. Additionally, the list now incorporates more detailed classifications for disorders related to the hematological system, endocrine responses, and neurological functions, ensuring comprehensive coverage of potential adverse events.
Implications for Stakeholders
Veterinary professionals and pharmaceutical companies must adapt to these changes by updating their reporting systems and training staff accordingly. Accurate reporting using the revised terminology will facilitate better monitoring of medicinal product safety, leading to improved animal health outcomes and more informed regulatory decisions.
- Enhanced precision in adverse event reporting improves data quality.
- Streamlined terminology assists in quicker identification of safety signals.
- Mandatory updates require timely adjustments to existing reporting frameworks.
- Improved clarity benefits both veterinary practitioners and regulatory bodies.
Adopting the updated VeDDRA terms will not only comply with EMA regulations but also contribute to a more robust pharmacovigilance system. Veterinary stakeholders are encouraged to review the changes in detail on the EMA website and implement necessary adjustments to their reporting procedures. This proactive approach ensures that adverse events are accurately captured and addressed, ultimately safeguarding animal welfare and public health.
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