MedDRA

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A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for safety information data entry, retrieval, evaluation, and presentation. Also, it is the adverse event classification dictionary.

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