In September 2025, MedDRA version 28.1 was released, the global medical-regulatory dictionary used for adverse event coding and safety data analysis. The semi-annual update, implemented on 3 November 2025, consolidates terminology at the PT and LLT levels, expands language availability, and introduces a redesigned Desktop Browser, with direct impacts on coding, standardised queries, and historical data comparability.
At a glance: what’s new in MedDRA 28.1
Version 28.1, as mentioned in the official document What’s New MedDRA Version 28.1, is a simple change version: updates apply to PT and LLT only, with no changes at higher levels. Versus 28.0 there is a net increase of +243 PT and +697 LLT (90,471 LLT in total, 81,143 current). SMQs do not increase in count but receive 225 adjustments to their component PTs; totals remain 110 Level-1 topics and 230 including associated sub-SMQs. On languages, Norwegian, Slovak and Slovenian bring availability to 27 languages overall, and the French translation is aligned to the Terminologia Anatomica, the international standard for anatomical terminology, with about 1,400 terms updated. Among tools, the MedDRA Desktop Browser 5.0 debuts with a redesigned interface and consolidated settings. No proactive requests were implemented in this cycle.
What changes in 28.1 for pharmacovigilance
Version 28.1 is a “simple change version”: changes affect only PT and LLT, with no updates to higher levels. A total of 1.412 change requests were considered; 1.032 were approved, 367 not approved, and 13 remain pending. To analyse differences between versions and assess promotions/demotions of terms, users can rely on the MedDRA Version Analysis Tool (MVAT), which provides results aligned with the Version Report included in the distribution package. Between releases, weekly supplemental updates in English are available and can be consulted via the Web Browser or MVAT.
Quantitatively, total LLTs increase to 90.471, with 81.143 current terms.
SMQ: updates without new queries
No new SMQs were introduced in 28.1. There were 225 approved changes to PTs within existing SMQs. With the publication of MedDRA 28.1 there are 110 Level-1 SMQ topics (i.e., main topics), for a total of 230 SMQs including the sub-SMQs associated with Level-1 SMQs.
Proactive requests
MedDRA’s proactive maintenance allows users to propose cross-cutting interventions to correct inconsistencies and improve terminological coherence and quality outside the standard change-request flow. In the cycle leading to 28.1, no proactive proposals were implemented; the MSSO nevertheless keeps a public list of proposals received and their status in the Change Requests section of the MedDRA website, and invites the community to submit substantiated suggestions to the Help Desk, clearly indicating scope and regulatory/clinical justification. This channel remains essential for user-driven evolution of the terminology, even in a consolidation release like 28.1.
Languages: MedDRA available in 27 versions
Version 28.1 adds Norwegian, Slovak, and Slovenian, bringing the total number of available languages to 27. Bulgarian, Danish, Maltese, and Romanian translations are in development; ICH has approved the start of the Uzbek translation.
Terminologia Anatomica in French: broad alignment
The French translation receives an alignment to the Terminologia Anatomica, with approximately 1,400 terms updated. Examples include “Fracture de la rotule” updated to “Fracture de la patella”; the full list appears in the Version Report. This alignment improves precision and uniformity for French-language users.
MedDRA Desktop Browser 5.0: what’s genuinely new
In July 2025, the MSSO released the MedDRA Desktop Browser (MDB) 5.0 with a refreshed design and an interface aligned to the Web-Based Browser introduced in December 2024. The stated goal is to simplify the user experience and place search functionality by far the most frequently used at the centre. All functions from previous versions remain available, with a consolidated settings menu that allows users to tailor the application’s behaviour to operational needs. The new MDB 5.0 can be downloaded from the MedDRA website’s Download area (login required; a Self-Service Application is available to obtain credentials). The MDB 4.1 app remains available on the MedDRA site. The MSSO Help Desk is available for support.
How to update the pharmacovigilance database to MedDRA 28.1
Each new MedDRA release must be incorporated into the pharmacovigilance database to ensure coding consistency, comparable analyses, and regulatory compliance. Max Application has installed MedDRA 28.1 on customers’ SafetyDrugs databases and continues to offer a free service to load new versions. This ensures that terminology is kept current without technical burden, reducing the risk of misalignment between systems and documentation.
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