MedDRA
MedDRA
MedDRA (pronounced: med-drah), an acronym for Medical Dictionary for Regulatory Activities, is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation.
Etymology
The term MedDRA is an acronym derived from the phrase Medical Dictionary for Regulatory Activities. The terminology was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and is maintained by the Maintenance and Support Services Organization (MSSO).
Related Terms
- ICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is a global body that brings together regulatory authorities and the pharmaceutical industry to develop and promote harmonized standards and guidelines to develop safe, effective, and high-quality medicines.
- MSSO: The Maintenance and Support Services Organization is responsible for the maintenance, development, and support of MedDRA.
- Pharmacovigilance: This is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
- Biopharmaceutical: A type of medicinal product manufactured in, extracted from, or semi-synthesized from biological sources.
Pronunciation
MedDRA is pronounced as "med-drah".
See Also
- Clinical Data Interchange Standards Consortium
- Common Technical Document
- Electronic Common Technical Document
External links
- Medical encyclopedia article on MedDRA
- Wikipedia's article - MedDRA
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