The European Medicines Agency (EMA) has unveiled significant upgrades to its EudraVigilance Veterinary (EVVet) system, enhancing the monitoring and reporting of adverse reactions associated with veterinary medicinal products within the European Economic Area (EEA).
EMA’s revamped EVVet platform serves as a comprehensive data-processing network dedicated to managing and analyzing reports of suspected adverse events linked to authorized veterinary medicines. This update aligns with the provisions of the Veterinary Medicinal Products Regulation (EU) 2019/6, ensuring robust pharmacovigilance across the Union.
New Reporting Standards Introduced
A key feature of the update is the transition from the Data Elements Guideline (DEG) to the VICH standard format for adverse event reporting. This shift aims to harmonize data across member states, facilitating more efficient signal detection and data analysis. During the transition period, both DEG and VICH formats will be accepted, allowing stakeholders ample time to adapt their reporting systems.
Guidance for Stakeholders
EMA has provided comprehensive guidance documents to assist marketing authorization holders and national competent authorities in navigating the new EVVet system. These resources include user manuals for the EVWeb interface and the EVVet Data Warehouse, ensuring users can effectively submit and access adverse event reports. Additionally, the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) has been updated to standardize clinical terms used in reporting.
Inferences:
- Stakeholders must transition to the VICH standard to comply with new regulatory requirements by the specified deadlines.
- The updated EVVet system is expected to enhance the accuracy and timeliness of adverse event data analysis.
- Comprehensive training and support will be crucial for seamless adaptation to the new reporting standards.
The EMA’s enhancements to the EVVet system represent a pivotal step towards strengthening veterinary pharmacovigilance within the EU. By adopting the VICH standard, the agency ensures a more unified and efficient approach to monitoring medicinal products, ultimately safeguarding animal health and consumer safety. Stakeholders are encouraged to utilize the provided guidance and participate in upcoming training webinars to fully leverage the system’s capabilities. These improvements not only facilitate better data management but also promote proactive measures in identifying and mitigating potential risks associated with veterinary medicines. As the regulatory landscape evolves, the EMA’s commitment to transparency and collaboration will be essential in maintaining high standards of veterinary healthcare across Europe.
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