Medical Dictionary for Regulatory Activities(MedDRA)
A standardized medical terminology used internationally by regulatory authorities and the pharmaceutical industry for coding adverse events and medical history.
Usage Examples
- All adverse events in the Phase 3 CSR were coded using MedDRA version 26.1.
- The PSUR mapped postmarket events from multiple sources to MedDRA preferred terms.
- The safety database was re-coded when MedDRA 27.0 updated the hepatic disorders hierarchy.
What is MedDRA?
MedDRA (Medical Dictionary for Regulatory Activities) is a clinically validated, internationally standardized medical terminology developed and maintained by the ICH MedDRA Maintenance and Support Services Organization (MSSO). It is used by regulatory authorities (FDA, EMA, PMDA, Health Canada, TGA) and the pharmaceutical industry to code adverse events, medical history, medical devices, product indications, and other medical information in a consistent way.
MedDRA has a five-level hierarchy: System Organ Class (SOC) → High Level Group Term (HLGT) → High Level Term (HLT) → Preferred Term (PT) → Lowest Level Term (LLT). When clinical trial or postmarket safety data is coded, investigator-reported terms map to LLTs which aggregate up through the hierarchy. This enables consistent cross-study and cross-sponsor analysis.
MedDRA releases occur twice annually. Sponsors must keep clinical safety databases current, which means re-mapping and re-analyzing data when MedDRA terminology changes. MedDRA use is mandated in regulatory submissions worldwide: ICSRs, periodic safety reports (PSUR, PBRER, DSUR), clinical study reports, and regulatory databases.
Regulatory Context
This term appears most often in pharmacovigilance workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside ICH M1, FDA REQUIREMENTS.
When This Matters
- All adverse events in the Phase 3 CSR were coded using MedDRA version 26.1.
- The PSUR mapped postmarket events from multiple sources to MedDRA preferred terms.
- The safety database was re-coded when MedDRA 27.0 updated the hepatic disorders hierarchy.
Common Mistakes
- Treating safety signal reviews as periodic instead of continuous.
- Not linking new enforcement letters to internal CAPA and labeling workflows.
- Using static templates for dynamic benefit-risk communication updates.
Related Regulations
Frequently Asked Questions
The ICH MedDRA Maintenance and Support Services Organization (MSSO). ICH governs the terminology, and MSSO releases updates semi-annually (typically March and September). Sponsors and regulators subscribe to MedDRA and apply updates to maintain compliance.
For ICH-region submissions (US FDA, EU EMA, Japan PMDA, Canada Health Canada), MedDRA is the standard coded medical terminology for adverse events and medical history in ICSRs, periodic reports, and CSRs. Non-ICH jurisdictions may also accept MedDRA. It is the de facto global standard.
Twice per year, typically March and September. Updates add new terms, deprecate old terms, and reorganize hierarchies based on scientific and clinical evolution. Sponsors implement the new version in their safety databases and re-code historical data as needed to maintain current analysis.
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Sources & References
