MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology used to classify and code adverse events (AEs) and medical history data in clinical trials, post-marketing surveillance, and other types of medical research. It is maintained and developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
MedDRA is a hierarchical system of coding, with each term assigned a unique code number. The terms are organized into five levels, with the higher levels being broader and more general, and the lower levels being more specific. The lowest level of terms, known as Preferred Terms (PTs), describe specific medical concepts and are used to classify and code AEs and other medical data.
MedDRA is used by regulatory authorities around the world, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as a standard for coding and reporting AEs in clinical trials and post-marketing surveillance. It is also used by the pharmaceutical industry to prepare regulatory submissions and to analyze safety data from clinical trials and other studies.
The use of MedDRA helps to ensure consistency and accuracy in the classification and reporting of AEs and other medical data across different studies and regulatory agencies. It also helps to facilitate the exchange of safety information between regulatory authorities and the pharmaceutical industry.