VeDDRA Terminology: Guidelines for Adverse Reaction Reporting

This document explains the VeDDRA terminology for reporting adverse reactions in animals and humans, providing guidelines on selecting appropriate terms at the Lowest Level Term (LLT) level, changes to System of Controls (SOCs), and specific coding for cases like death and anaphylaxis. It outlines the four-level hierarchical structure of VeDDRA and distinguishes between clinical signs, emphasizing the correct use of LLT terms.

The guidance highlights the importance of using the LLT ‘Death’ term for reporting adverse events, the LLT ‘Unrelated Death’ term for anaphylaxis, and LLT terms for local reactions at application, injection, or implantation sites. It also covers the appropriate use of LLT terms for various clinical signs, including ear and labyrinth disorders, pain and discomfort.

Recent updates to the document include new sections on anaphylaxis, hypersensitivity reactions, and information on suspected infectious agent transmission, reversal to virulence, transmission of a vaccine strain, recombination of a vaccine strain, and prolonged shedding of a vaccine strain.

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-notes-use-veterinary-dictionary-drug-regulatory-activities-veddra-terminology-reporting-suspected-adverse-events-animals-humans-rev16_en.pdf##~https://www.ema.europa.eu/en/news-events/whats-new

Region: European Union