The Medical Dictionary for Regulatory Activities (MedDRA) is a multi-axial, five-tiered hierarchical terminology used by regulatory authorities and the biopharmaceutical industry for the coding (classification) of clinical data in adverse event/adverse drug reaction (AE/ADR) reports. The terminology — developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) — is maintained by an independent organization that distributes MedDRA via subscription. The activities of this organization — the Maintenance and Support Services Organization — are overseen by the MedDRA Management Board, which itself reports to the ICH Steering Committee.
MedDRAwas developed to overcome some of the limitations of previousAE/ADRcoding terminologies and to provide a single, multilingual resource for the classification of AE/ADRdata. Currently, MedDRA’s use is mandated for various types of regulatory reporting in the EU and Japan; it is widely used by the biopharmaceutical industry in all three ICH regions (US, EU and Japan). The US Food and Drug Administration has used MedDRA in its Adverse Event Reporting System for over a decade.
MedDRA provides a robust, vigorously maintained standard terminology for AE/ADR reporting with sufficient granularity of concepts and logical medical groupings within its hierarchy of terms. However, because of the size and specificity of MedDRA, as well as the organization of some of its groupings, retrieval and aggregation of coded AE/ADR data can sometimes present a challenge. Standardised MedDRA Queries (SMQs) have been developed in part to address this challenge. As of the time of writing, there are nearly 70 SMQ topics available to MedDRA users.
MedDRA’s use continues to expand 10 years after its official launch, driven primarily by the needs of — and input from — its user community.
KeywordsBiopharmaceutical Industry Uppsala Monitoring Centre Individual Case Safety Report Periodic Safety Update Report Lower Level Term
The author is a member of the MedDRA Maintenance and Support Services Organization (MSSO) within Northrop Grumman Information Systems. MSSO does not own MedDRA but distributes it via subscription. MSSO also provides MedDRA-related services (e.g. training) to subscribers. No sources of funding were used to assist in the preparation of this article.
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