MedDRA Announcement: MedDRA Version 27.0 & MedDRA Messenger – PharSafer® – Global Clinical and Post Marketing Drug Safety

MedDRA Announcement: MedDRA Version 27.0 & MedDRA Messenger

Highlights from MedDRA’s March, 2024 Update

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

General Release:MedDRA Version 27.0 was announced on 1st March, 2024 and comprises of a total of 1,582 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.

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 updates were also made to SMQs related to congenital familial and genetic disorders, immune-mediated/autoimmune disorders, and malignancy-related therapeutic and diagnostic procedures.

New Language Translations and Interoperability Efforts

Language Expansions: With the release of Estonian and Finnish translations in 2023, MedDRA 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.

Points to Consider Documents and Subscription Updates

Documentation Updates: The MedDRA Points to Consider (PtC) 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.

Subscription Model Changes: In response to MedDRA's growth, it has also been mentioned that subscription rates for 2024 have been reduced by 10%. Moreover, it has also been mentioned that changes to the commercial level definitions will impact approximately 600 organisations, allowing a broader range of users to benefit from reduced rates.

Training and 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 also plans to continue offering a mix of in-person and online training sessions.

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

Overall, the MSSO's update for March, 2024 signifies a commitment to enhancing MedDRA's global utility and accessibility. Through language expansions, interoperability 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 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.

For any questions or assistance for how to best navigate these updates and their implications for your safety operations, please do not hesitate to contact our team.

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For any questions or to further discuss how PharSafer® can assist with your needs, do not hesitate to contact us or Book a Meeting.