MedDRA is a rich and highly specific standardised medical terminology first developed in the late 1990s. It is now updated twice per year in 27 languages.
MedDRA facilitates the sharing of regulatory information internationally for medical products used by humans, including pharmaceuticals, vaccines and drug-device combination products.
A powerful tool, MedDRA is used for registration, documentation and safety monitoring of medical products before and after a product has been authorised for use.
The MedDRA Steering Committee is responsible for the operational aspects of MedDRA and reports to the ICH Management Committee.
