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 (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation.
Many other industries, including tobacco and cosmetics, are also beginning to use MedDRA for capturing adverse health events.
In developing and continuously maintaining MedDRA, ICH endeavours to facilitate the exchange of clinical information through a single standardized international medical terminology that can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.
[8] As a result, MedDRA is designed for use in the registration, documentation, and safety monitoring of medicinal products through all phases of the development life cycle.
[8] The single standardized terminology offers several clear advantages for regulators, industry, and other stakeholders: The MedDRA dictionary is organized with a five-level hierarchy.
The higher levels (HLT, HLGT, and SOC), as well as SMQs, are used for searching and for organizing and subtotalling outputs.
[12] The terminology was not developed as a formal classification or taxonomy; each level in the hierarchy may reflect a variable degree of specificity or “granularity” from one System Organ Class to another.
Grouping terms are pre-defined in the terminology and not selected on an ad hoc basis by data entry staff.
MedDRA is available free for all regulators worldwide, academics, health care providers, and non-profit organizations.
The final decisions are based on multiple factors including the Points to Consider documentation, implications on legacy data, and language considerations internationally.
[16] The MSSO frequently incorporates feedback from the user community to stay abreast of its unique perspectives and nuanced needs.