MedDRA Version 29.0 Update: Key Changes, Operational Impact and What Pharmacovigilance Teams Should Do Next

Introduction:

 

The release of MedDRA Version 29.0 (March 2026) represents one of the more operationally significant updates in recent MedDRA cycles. Whilst MedDRA upgrades are routine for pharmacovigilance teams, this version introduces terminology and structural changes that will directly affect coding consistency, case processing workflows, signal detection outputs and inspection readiness.

Most notably, the introduction of the new Preferred Term (PT) “Suspected off label use” reflects a pragmatic shift in how real-world safety data can be interpreted and coded – reducing unnecessary follow-up burden while increasing expectations around governance, consistency and documentation.

In this article, we outline the key updates in MedDRA Version 29.0, their operational implications, and the practical steps pharmacovigilance teams should be taking now.

 

What Is MedDRA Version 29.0?

 

MedDRA Version 29.0 was released on 1 March 2026 following review of more than 1,300 change requests, with updates affecting terminology across multiple levels of the MedDRA hierarchy.

The release includes terminology refinements, structural adjustments, updates to Points to Consider guidance, and continued progress across mapping and integration initiatives supporting global regulatory reporting environments.

 

Key Changes in MedDRA Version 29.0

 

1. Introduction of PT “Suspected off label use”

The most operationally significant development in Version 29.0 is the addition of the new PT “Suspected off label use,” with aligned LLTs reflecting those under PT Off label use.

Historically, confirming off-label use required evidence of intent, meaning follow-up was often necessary where cases described unauthorised use but did not explicitly confirm intentionality. In practice, this created inefficiencies, inconsistencies across datasets and avoidable operational burden.

 

The new term allows organisations to code based on medical judgement where appropriate, provided:

• The rationale is clearly documented
• Decision-making is consistent and defensible
• Medication error scenarios are excluded

For many pharmacovigilance teams, this will streamline workflows while improving alignment between datasets and real-world use patterns.

 

2. Structural and Terminology Updates

Other notable updates include:

• Creation of a new HLT for poliovirus infections and consolidation of related hierarchies
• Retirement of several “secondary malignancy” terms to avoid ambiguity with metastasis terminology
• Movement and refinement of selected medication error and product-use terms
• Whilst less visible operationally, these changes still warrant review as they may affect coding alignment, trending outputs and reconciliation workflows across programmes

 

3. Points to Consider (PtC) and Governance Updates

Version 29.0 also includes updates to the MedDRA Term Selection: Points to Consider document, including new guidance relating to off-label use and suspected off-label scenarios.

These updates reinforce the need for structured governance frameworks across coding and case processing activities.

 

4. Mapping and Systems Integration Developments

Additional developments relevant to global PV systems include:

• Continued ICD-10 to MedDRA mapping enhancements supporting interoperability
• Ongoing collaboration with IMDRF to align device reporting terminology
• Availability of MedDRA API functionality supporting automated integration into PV workflows

Together, these reflect a broader shift towards more integrated and automation-enabled pharmacovigilance operations.

 

Operational Impact: What Pharmacovigilance Teams Should Focus On

 

From an operational perspective, organisations should prioritise the following immediately:

Coding Governance and SOP Alignment: Existing procedures may not fully address suspected off-label use decision frameworks. SOPs, coding conventions and training materials should be reviewed and updated accordingly.

Consistency Across Teams and Vendors: Alignment across internal teams, affiliates and outsourced partners is essential to avoid variability and inspection risk.

Signal Detection and Reporting Considerations: Changes in coding practice may influence trend outputs and signal detection sensitivity. Early assessment helps avoid disruption.

Inspection Readiness and Documentation Standards: Clear audit trails and documented rationale will be essential to demonstrate defensible decision-making.

 

How PharSafer Supports MedDRA Version Upgrades

 

As a specialist global CRO in pharmacovigilance and regulatory compliance, PharSafer supports organisations across clinical development and post-authorisation settings with end-to-end MedDRA upgrade implementation.

In our experience, organisations that treat MedDRA upgrades as purely technical exercises often encounter avoidable operational and inspection challenges.

Our support includes:

• Impact assessments across systems and programmes
• SOP development and governance alignment
• Coding framework design and oversight
• Implementation planning and validation support
• Ongoing operational delivery and quality oversight

With deep expertise across global safety environments, we ensure MedDRA upgrades are delivered efficiently, consistently and compliantly – without disruption to critical workflows.

 

PharSafer Perspective

 

MedDRA Version 29.0 reflects a clear and necessary shift towards more pragmatic pharmacovigilance operations – particularly through the introduction of “Suspected off label use”. In our view, the change is welcome, but it also raises expectations. Organisations will need stronger governance, clearer coding frameworks and greater consistency across global teams to apply it confidently and defensibly.

From our experience supporting complex global safety programmes, the challenge is rarely understanding the change itself – it is implementing it consistently across systems, vendors and workflows without disrupting delivery timelines or inspection readiness.

At PharSafer, we approach MedDRA upgrades as an operational exercise rather than a theoretical one. We support organisations with structured impact assessments, SOP alignment, coding governance frameworks and implementation oversight to ensure changes are applied consistently across clinical and post-authorisation environments. Where appropriate, we also support delivery through RAPTAR®, enabling standardised, traceable and scalable workflows that help maintain coding consistency while reducing manual burden across global programmes.

Ultimately, MedDRA upgrades should strengthen – not complicate – pharmacovigilance operations. With the right governance, processes and infrastructure in place, organisations can implement Version 29.0 efficiently while maintaining full confidence in their data, reporting and compliance position.

 

PharSafer remains committed to supporting our clients throughout this transition.

 

If you have any questions or require further guidance, please contact us directly:

 

enquiries@pharsafer.com

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