What is "meddra"

MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary (and thesaurus) used by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Originally available in English and Japanese, MedDRA is now also translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Portuguese and Spanish. MedDRA is widely used internationally, including in the United States, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.