MedDRA

MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire 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). MedDRA is used in the US, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.
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Medical Dictionary for Regulatory Activities (ICH) Medical terminology for international electronic transmission of clinical-trial data and adverse event reporting for pre- and postmarketed compounds.