Supplemental Codes for Coronavirus Updated in MedDRA by ICH

The ICH updated the MedDRA (Medical Dictionary for Regulatory Activities) with new supplemental terms and corresponding codes related to COVID-19.

ICH said that “The coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue.”

ICH also says that new supplemental terms are already available via the MedDRA Maintenance and Support Services Organization’s (MSSO) web-based browser, they will not become official until the release of MedDRA Version 23.1 in September.

Until implementation of MedDRA Version 23.1, the existing, more general, terms and codes should be used.

The proposed supplemental terms aim to be more specific than existing terms related to COVID-19. For instance, an existing term “LLT viral test” will be replaced with a supplemental term for “PT SARS-CoV-2 test.”

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