What’s New MedDRA Version 28.1

This document is an official release note from the Maintenance and Support Services Organization (MSSO) detailing the changes and updates introduced in MedDRA (Medical Dictionary for Regulatory Activities) Version 28.1, released in September 2025. MedDRA is a standardized medical terminology used for regulatory communication and data analysis in the healthcare industry.

1. Document Overview

This section introduces the purpose of the document: to inform users about all changes made to MedDRA between Versions 28.0 and 28.1. It outlines the structure, directing readers to subsequent sections for specific details on change requests, new developments, and a summary of the changes’ impact.

2. Version 28.1 Change Requests

This section explains the origin and scope of the changes.

• Type of Version: Version 28.1 is a “simple change” version. This means modifications were made only at the PT (Preferred Term) and LLT (Lowest Level Term) levels, leaving higher-level terms (HLT, HLGT, SOC) unchanged.
• Change Request Processing: A total of 1,412 change requests were processed.
  • 1,032 were approved and implemented.
  • 367 were not approved.
  • 13 were suspended for future consideration.
• Tracking Changes: Users are directed to tools like the Version Report and the MedDRA Version Analysis Tool (MVAT) to see specific changes (new terms, demotions, promotions, etc.).

Figure 2-1 (Page 6): Net Changes of Terms per SOC
This bar chart provides a high-level view of which medical areas were most affected. It shows the net number of terms added (or changed) within each System Organ Class (SOC). For example:

• Investigations saw the highest number of changes (+203 terms).
• Surgical and medical procedures also had significant updates (+164 terms).
• SOCs like Ear and labyrinth disorders had very few changes (+4 terms).

3. New Developments in Version 28.1

This section highlights significant initiatives and updates beyond routine term changes.

• 3.1 Standardised MedDRA Queries (SMQs):
  • No new SMQs were added in this version.
  • However, 225 existing PTs were added to or modified within existing SMQs to improve the accuracy and scope of these predefined sets of terms used for safety signal detection.
• 3.2 Proactivity Requests:
  • No new proactivity proposals (suggestions for broad improvements to MedDRA’s structure) were implemented in this cycle. Users are encouraged to submit ideas to the MSSO.
• 3.3 New MedDRA Languages:
  • This is a major development. Three new languages were released: Norwegian, Slovak, and Slovenian, bringing the total number of available languages to 27.
  • These are part of an initiative to support electronic product information in the European Economic Area (EEA).
  • Other languages are under development, including Bulgarian, Danish, Maltese, Romanian, and Uzbek.
• 3.4 French Translation Terminologia Anatomica Update:
  • A significant project was completed to update French anatomical terms to align with the modern international standard, Terminologia Anatomica (TA).
  • Approximately 1,400 terms were updated from older, “classical” French terms to the new TA-approved terms.
  • Examples:
    • “Fracture de la rotule” → “Fracture de la patella” (Patella fracture)
    • “Hématome du tronc cérébral” → “Hématome du tronc de l’encéphale” (Brain stem hematoma)
• 3.5 Updated MedDRA Desktop Browser (MDB):
  • A new version (MDB 5.0) was released in July 2025.
  • The key improvement is a redesigned user interface that matches the web-based browser, focusing on simplifying the search function, which is the most frequently used feature.

4. Summary of Changes

This section provides quantitative data on the impact of Version 28.1.

• 4.1 Summary of Impact on the Terminology :
  • This table shows the change in record counts across all MedDRA distribution files.
  • Key increases:
    • +243 PTs (from 26,920 to 27,163)
    • +697 LLTs (from 89,774 to 90,471)
    • +658 records in the SMQ content file (smq_content.asc), reflecting the 225 PT changes mentioned earlier.
• 4.2 & 4.3 Impact on Records and Term Counts by SOC:
  • These tables provide detailed counts for developers and database administrators, showing the number of changed records in sequential update files (*.seq) and the total number of terms within each SOC.
• 4.4 LLT Currency Status Changes :
  • This table explains why specific LLTs were made “current” or “non-current.”
  • Example 1 (Made Current): “Narcolepsy with cataplexy” was reinstated as a current term. While the official terminology is now “Narcolepsy type 1,” the older term is still widely used and understood.
  • Examples 2 & 3 (Made Non-current): “Thrombocytopaenic purpura” and “Purpura thrombopaenic thrombotic” were made non-current because their British English spellings were determined to be no different from the American English versions, making the duplicate terms unnecessary.