RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 4 > ICH: MedDRA updated with supplemental codes for coronavirus

ICH: MedDRA updated with supplemental codes for coronavirus

Posted 01 April 2020 | By Michael Mezher 

ICH: MedDRA updated with supplemental codes for coronavirus

The International Council for Harmonisation (ICH) on Wednesday announced that the Medical Dictionary for Regulatory Activities (MedDRA) is being updated with new supplemental terms and corresponding codes related to coronavirus disease (COVID-19).
 
“The coronavirus pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue,” ICH says, noting that more terms are in the process of being reviewed.
 
While ICH says the 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 then, ICH says that 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.”
 
ICH says it will continue to provide updates as the new terms are added.
 
ICH

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe