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MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology system used globally for coding and reporting adverse events and product quality issues in pharmaceutical and medical device trials. MedDRA was first introduced in 1999 and is developed and maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

MedDRA is used by regulatory agencies, pharmaceutical companies, and research institutions worldwide. The system provides a comprehensive and structured vocabulary for classifying adverse events, product quality complaints, and other relevant medical events. MedDRA enables consistent and accurate reporting across different languages and regions.

The MedDRA dictionary contains over 75,000 preferred terms and more than 60,000 related terms, which are organized into a hierarchical structure. This structure facilitates efficient coding and quick access to relevant information. The preferred terms are categorized into several layers, including:

* System Organ Class (SOC): Higher-level classifications of body systems (e.g., nervous system, gastrointestinal system)

* High-Level Group Terms (HLGTs): Intermediate-level classifications of disease or treatment areas (e.g., infections, cancers)

* MedDRA preferred terms: Specific medical terms

Regulatory authorities and pharmaceutical companies endorsed MedDRA as a standard for adverse event reporting in 2004. The system is widely used in clinical trials, pharmacovigilance, and regulatory submissions. It is also available in multiple languages.

MedDRA is developed and maintained by the MedDRA Maintenance and Support Committee, which includes representatives from regulatory agencies, pharmaceutical companies, and research institutions. The committee continually updates and expands the system to ensure it remains current and effective for its users.