A new version of the Medical Dictionary for Regulatory Activities (MedDRA) has just been released.

What is MedDRA?

MedDRA is the acronym for Medical Dictionary for Regulatory Activities. It’s an international medical terminology used by the pharmaceutical industry, medical device industry and regulatory agencies throughout the drug development process, in clinical trials and for postmarketing activities such as pharmacovigilance (periodic safety update reports and adverse drug reactions), clinical reports, data presentation and coding.

It classifies diseases, diagnoses, signs, symptoms, therapeutic indications, investigations and procedures, and medical/social/family history. It doesn’t cover drugs (except as an associated adverse event), equipment or device terminology (except as a device failure), numerical values, study designs or demographics.

Why do we need it?

MedDRA ensures global standardisation of terminology by regulatory agencies – the FDA, EMA and PMDA (Japan) –, pharmaceutical companies and clinicians. And translators. More.

See: Signs & Symptoms of Translation

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