MedDRA Announcement: MedDRA Version 27.0 & MedDRA Messenger

Highlights from MedDRA Version 27.0 and March 2024 Updates

In the most recent update issued by the MedDRA Maintenance and Support Services Organisation (MSSO), an in-depth look is offered at the most recent developments and projects related to MedDRA Version 27.0.

This update is crucial for stakeholders in the pharmaceutical regulatory sector, and PharSafer has reviewed the recent announcement and compiled the key considerations as follows:

MedDRA Version 27.0 Release Overview:

General Release: MedDRA Version 27.0 was announced on 1st March, 2024 and comprises of a total of 1,582 MedDRA change requests, with 1,206 approved and implemented. This complex change version also sees the introduction of two complex changes aimed at improving analysis and differentiation between product application methods.

Standardised MedDRA Queries (SMQ updates): From the information provided, whilst no new Standardised MedDRA Queries (SMQs) were added, 311 PT changes to existing SMQs were indeed approved. Significant Standardised MedDRA Queries (SMQ updates) were also made to SMQs related to congenital familial and genetic disorders, immune-mediated/autoimmune disorders, and malignancy-related therapeutic and diagnostic procedures.

Language Expansions and Interoperability in MedDRA Version 27.0

• Language Expansions: With the release of Estonian and Finnish translations in 2023, MedDRA Version 27.0 has officially expanded to include 21 languages now available for download. Additional translations for Romanian, Slovak, and Bulgarian are also underway to support the Electronic Product Information (ePI) initiative within the European Economic Area (EEA).
• Interoperability Plans: Within MSSO's 2024 roadmap, it is outlined that MSSO will be enhancing interoperability with other terminologies, including SNOMED CT and ICD-11, to broaden access to data and improve usability across different systems.

MedDRA Points to Consider (PtC) Guidance and Subscription Model

Documentation Updates: The MedDRA Points to Consider (PtC) guidance documents, which undergo yearly updates, are essential for term selection and data retrieval. It has been communicated that these are scheduled for an update in March, 2024, with an updated Companion Document also expected to be released, providing additional guidance on specific regulatory topics, including manufacturing and quality system issues.

MedDRA Subscription Model Changes: In response to MedDRA's growth, MedDRA subscription model changes have resulted in rates being reduced by 10%. Moreover, changes to the commercial level definitions will impact approximately 600 organisations, allowing a broader range of users to benefit from reduced rates as part of the MedDRA MSSO updates 2024.

Training and Global Outreach Activities

• Global Training Initiatives: The MSSO has resumed face-to-face training globally, with over 16,000 attendees from 99 countries participating in 58 in-person classes and 135 webinars in 2023. The MSSO plans to continue offering a mix of in-person and online training sessions for MedDRA Version 27.0.

• Outreach and User Engagement: The MSSO's participation in User Group meetings and conferences worldwide facilitates direct engagement with the MedDRA community, offering a platform for discussions on MedDRA-specific topics and updates.

Looking Forward with MedDRA Version 27.0

Overall, the MedDRA MSSO updates 2024 signify a commitment to enhancing MedDRA Version 27.0's global utility and accessibility. Through language expansions, terminology interoperability (SNOMED CT and ICD-11) efforts, and user-focused documentation and training, the MSSO aims to support the evolving needs of the pharmaceutical and regulatory communities.

Furthermore, future updates and continued outreach are planned to maintain an open dialogue with users and ensure MedDRA Version 27.0 remains an essential tool in the regulatory landscape. PharSafer® will continue to monitor this and provide updates for the benefit of our clients as they become available.

To maintain compliance and manage seamless processing across safety databases, explore our automated safety database solution, RAPTAR. For any questions or assistance on how to best navigate these MedDRA Version 27.0 updates and their implications for your safety operations, please do not hesitate to contact our team.