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Apr 17

MedDRA 23.0 COVID-19 Re-Release

Earlier today, MedDRA MSSO conducted a webinar on the topic of the upcoming re-release of MedDRA 23.0, which was initially released on 10th April 2020.

Due to the impact COVID-19 has had on the industry, the decision was made by MedDRA MSSO to re-release 23.0 for benefit of inclusion and re-organisation of specific terms related to COVID-19 (coronavirus), with all other changes witnessed in the initial release of 23.0 remaining present.

As mentioned on the MedDRA website, this exceptional re-release of 23.0 will become available on 19th April, 2020 and will be released with translations in both English and Japanese, with further languages set to become available by 3rd May 2020.

Whilst the transition date for version 23.0 remains set for 4th May 2020, the re-release is set to become available via the MedDRA website’s designated page on 19th April 2020, with unzip passwords remaining the same as those for the March release.

MedDRA MSSO have also communicated that they strongly recommend changing to the re-release of 23.0, as opposed to waiting for the release of 23.1, due to the fact that 23.1 will be based on the re-release of 23.0 and is currently scheduled for release on 1st September 2020.

Moreover, following the re-release, organisations have also been informed that any existing COVID-related cases within the database should be re-coded to correlate with these more specified added terms, in addition to notifying that the database field (and XML field) for the MedDRA version should still display as 23.0, as this is a re-release of an existing version and not a new version release.

However, within the information provided, it is worth noting that points to consider documents will not be updated within this re-release and the SMQ’s included in version 23.0 will remain as unchanged. Though, this has been communicated as something in progress, with MedDRA MSSO stating a designated COVID SMQ is being considered and a specified COVID HLT is set to be included in the April 19th re-release.

In regards to the EMA IME list, it has been communicated that this will be updated with COVID terms and made available on the EMA website – though, the date for this is still to be confirmed – with internal training on the update able to be completed within a reasonably short time frame, following the transition date of 4th May, 2020.

Finally, MedDRA MSSO have stated that version 23.1 will also contain some drug availability terms specific to COVID; in addition to requesting that any additional COVID specific term requests, desired for addition in version 23.1, will require to be submitted by 1st June 2020 – or by 1st December 2020, for version 24.0 – in order to allow sufficient time for MedDRA MSSO to process these requests in line with their outlined timescales.

PharSafer will keep you updated on this topic and any future updates as they are provided.

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