MedDRA
Medical Dictionary for Regulatory Activities
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
MedDRA is the standardized international medical terminology used to code adverse events, medical history, indications, and other regulatory data across the product lifecycle. Its hierarchy — from lowest-level terms up through preferred terms, high-level terms, high-level group terms, and system organ classes — lets safety data be entered specifically yet analyzed and exchanged consistently between sponsors and regulators. It is developed under ICH and versioned on a fixed release cycle.
Consistent MedDRA coding is what makes signal detection and aggregate safety reporting possible: two reviewers coding the same event to the same preferred term is a prerequisite for meaningful case-series and disproportionality analysis.
Standardized MedDRA Queries (SMQs) are pre-built groupings of terms that support retrieval of cases relevant to a medical condition of interest — a workhorse of pharmacovigilance signal work.
- —Five-level hierarchy: LLT → PT → HLT → HLGT → SOC
- —Enables consistent coding, exchange, and aggregate analysis
- —SMQs support condition-based case retrieval for signal detection
- —Maintained under ICH with scheduled versioned releases
MedDRA maintained under ICH by the MedDRA Maintenance and Support Services Organization (MSSO); used in ICH E2B individual case safety reporting.
Frequently asked questions
What does MedDRA stand for?
MedDRA stands for Medical Dictionary for Regulatory Activities.
What is MedDRA?
MedDRA is the standardized international medical terminology used to code adverse events, medical history, indications, and other regulatory data across the product lifecycle. Its hierarchy — from lowest-level terms up through preferred terms, high-level terms, high-level group terms, and system organ classes — lets safety data be entered specifically yet analyzed and exchanged consistently between sponsors and regulators. It is developed under ICH and versioned on a fixed release cycle.
Which regulations cover MedDRA?
MedDRA maintained under ICH by the MedDRA Maintenance and Support Services Organization (MSSO); used in ICH E2B individual case safety reporting.