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1. Massive Terminology Expansion

• 789 new LLTs (Lowest Level Terms)
• 291 new PTs (Preferred Terms)
• 23 promotions from LLT to PT
• 151 LLTs reassigned under different PTs
• These updates reflect evolving clinical language and regulatory needs

2. New Hierarchical Additions

• “Quality System Issues” added under SOC Product Issues
• “Rhabdoviral Infections” introduced under Infections and Infestations
• These new HLTs (High Level Terms) help capture emerging safety concerns

3. Language Expansion

• Icelandic added—MedDRA now supports 24 languages
• Translations underway for Bulgarian, Maltese, Norwegian, Romanian, Slovak, and Slovenian

4. Tool Enhancements

• Web-Based Browser (WBB) redesigned for better usability
• Integrated MVAT tool for comparing any two MedDRA versions
• Users can now submit change proposals directly from the browser

5. Updated Points to Consider (PtC) Documents

• New Section 5 added: Manufacturing and Quality System Issues
• Offers real-world coding guidance for deviations and nonconformities

6. Interoperability Mapping Projects

• ICD-11 to MedDRA mapping underway with WHO
• IMDRF Annex E mapped to MedDRA for medical device terminology alignment
• These efforts enhance global harmonization across regulatory systems