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Apr 06
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Inclusion of COVID-19 specific terms within MedDRA database

Due to the impact the current COVID-19 pandemic has had on the process involved with the reporting of events directly related to the coronavirus, MedDRA MSSO have released guidance for organisations with reporting responsibilities to follow when using appropriate terms within the database.

In summary, MedDRA has acknowledged the need for a focussed approach to reporting events caused by COVID-19, and have therefore commenced updating the MedDRA database for the inclusion of coronavirus specific terms – with several appropriate terms already successfully applied and more additions to follow.

Whilst this is a progressive step in combating the impact COVID-19 has had on the industry, through standardising the reporting procedure, these terms will not become available until the version 23.1 database upgrade becomes available in September, 2020.

Moreover, MedDRA MSSO have advised organisations to continue using existing and generic terms when reporting events which are related to COVID-19 specifically, with examples of these terms available within the current database version 23.0 – shown within their guidance document.

Additionally, MedDRA MSSO have asked for any additional, appropriate coronavirus related terms, that are yet to be included, to be submitted to WebCR for their consideration.

Regarding further announcements, MedDRA MSSO have communicated that further updates, regarding additional new coronavirus specific terms, will be provided before the official release of version 23.1.

PharSafer Comment:

The MSSO have reacted quickly to this global situation to enable Companies to record quickly and accurately the terms, signs and symptoms to be used for COVID-19 events. Since this is an evolving situation, terms will require reporting to the MSSO for possible inclusion for the next version.

PharSafer will continue to monitor these updates from MedDRA MSSO directly and inform you of any future notifications as we receive them.

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