17 December 2014

The factsheet provides information on the multilingual nature of the Medical Dictionary for Regulatory Activities (MedDRA), including how interoperability between all translations of MedDRA is achieved, as well as the multilingual support available to MedDRA users in the form of supporting documentation and electronic tools.

The primary intent of the ICH in developing the Medical Dictionary for Regulatory Activities (MedDRA) was to improve communication among and between industry and regulators by facilitating electronic communication. This objective was supported by having the terminology available in multiple languages. The first version of MedDRA was released in 1999 in English and Japanese.

Multilingual MedDRA Factsheet