MedDRA
- Stage boundary
- No direct role is recorded for Plan.
- Known limitation
- MedDRA is licensed, version-sensitive, and multiaxial; a coded term does not establish seriousness, expectedness, relatedness, or causality.
Decision support
Compare standards by the job they do
Place up to three profiles side by side. Focus on architectural role, evidence, and the first limitation to test—not on finding a single all-purpose standard.
Working set
Choose profiles
1 of 3 selected
MedDRATerminology
Decision lens
Compare roles before you compare maturity.
The useful question is not “Which standard wins?” It is “Which job must this part of the architecture perform, and what remains uncovered?”
- Start with the job
Decide whether you need guidance, a domain payload, exchange, semantics, governance, or a reusable release.
- Map lifecycle reach
Use the matrix to see where each profile has a direct role. A filled cell is coverage, not a quality score.
- Test the boundary
Read what each option leaves unresolved before judging maturity, confidence, or implementation fit.
Three-part assessment
See the reach, the gaps, and the evidence.
Read left to right. Lifecycle reach comes first; maturity remains an editorial roll-up, not certification.
01 · Lifecycle reach
Where each profile contributes directly
Coverage shows a recorded role at that readiness stage. It does not imply end-to-end implementation.
| Profile | Plan | Acquire | Harmonize | Exchange | Learn + reuse |
|---|---|---|---|---|---|
| MedDRATerminology | Medical Dictionary for Regulatory Activities has no direct role recorded in Plan. | Medical Dictionary for Regulatory Activities has a direct role in Acquire. | Medical Dictionary for Regulatory Activities has a direct role in Harmonize. | Medical Dictionary for Regulatory Activities has a direct role in Exchange. | Medical Dictionary for Regulatory Activities has a direct role in Learn + reuse. |
Direct role recordedNo direct role recorded
02 · Boundaries
What each option does not cover
These are design boundaries, not faults. Use them to identify the companion layers your architecture still needs.
03 · Detailed assessment
Check the fit and evidence behind the map
Use the source, status, and limitation together. A higher maturity label does not erase a scope mismatch.
| Assessment | MedDRAMedical Dictionary for Regulatory Activities |
|---|---|
| Purpose & coverage | Hierarchical coding of adverse events, medical history, indications, investigations, product issues, and related regulatory medical concepts. Best fitClinical-trial safety coding, individual case safety reports, aggregate safety analyses, and regulatory pharmacovigilance exchange. |
| Readiness stages | AcquireHarmonizeExchangeLearn + reuse |
| AI-ready contribution | The hierarchy supports safety aggregation and signal features, but automated coding requires human validation and cannot substitute for clinical causality assessment. |
| First limitation to test | MedDRA is licensed, version-sensitive, and multiaxial; a coded term does not establish seriousness, expectedness, relatedness, or causality. |
| Evidence | E1 + E2 High confidence Formal statusMedDRA 29.0 current production release ReviewSource-checked · watch |
| Maturity | Established Current ICH regulatory terminology with twice-yearly releases and version-aligned support documents |
| Sources & links | Official MedDRA 29.0 downloads (opens in a new tab)Read full profile |