IDMP wants data. Your RIM system manages documents.
ISO IDMP asks for products, substances, organisations, and pack data as structured, identified, resolvable data. Most of that information currently exists as narrative text in an SmPC and as rows in a system built to manage documents. TopQuadrant models it as governed data, reconciled to SPOR referentials and ready for the PMS API.
Trusted to govern the data behind the world's most regulated decisions.
Three submission regimes, two decommissioned EMA systems, one product master
EMA is retiring xEVMPD and SIAMED and replacing them with a FHIR-based Product Management Service. PMDA has mandated eCTD v4.0 since April 2026, the EU is targeting Q3 2026, and the FDA remains voluntary. A global regulatory function has to serve all of it from one product data model, or it maintains three and reconciles forever.
EMA deadline for PMS enrichment of pack size and manufacturing data for non-critical products, following the June 2026 date for ULCM and centrally authorised products.
ISO IDMP standards to satisfy at once: 11615, 11616, 11238, 11239, and 11240, all resolving against SPOR.
One governed product, substance, and organisation model serving EMA, FDA, and PMDA submissions.
Structured product data
Model the product as structured data
Medicinal products, pharmaceutical products, presentations, and pack sizes are modelled with the identifiers, relationships, and controlled values IDMP requires. What existed only as narrative in an SmPC becomes governed, queryable, submittable data.
- IDMP-shaped model. Products, substances, dose forms, routes, packaging, and units modelled to the standards.
- Extraction with review. Pull structured values out of narrative source documents, with a steward confirming each.
- Every value sourced. Each data element records the document, system, and person it came from.
SPOR referential alignment
Resolve to the identifiers EMA expects
Product data is only valid if the organisations, substances, and controlled terms behind it resolve to SPOR. Organisation Loc-IDs, substance identifiers, and RMS controlled vocabularies are governed here and reconciled continuously rather than at submission time.
- OMS, RMS, SMS alignment. Governed local records mapped to the SPOR identifiers, with mismatches surfaced.
- Entity resolution. Duplicate and variant organisation and manufacturing site records reconciled to one governed entity.
- PMS to xEVMPD reconciliation. See the gap between what you submitted and what PMS now needs.
Multi-region submission support
One model, three regulatory regimes
Regional requirements differ in structure, not in substance. Hold the product data once, express region-specific views for EMA, FDA, and PMDA, and keep the differences visible as governed mappings instead of as three divergent databases.
- Regional views. Generate the shape each authority requires from one governed source.
- eCTD version coexistence. Support v3 and v4.0 requirements without maintaining parallel product data.
- Divergence tracked. Where a region requires something different, the difference is modelled and owned.
Validation & audit
Fail validation in your system, before theirs
EMA portal business rules now govern technical validation. Express those rules as SHACL constraints and check your data continuously, so a gap is a violation on a dashboard rather than a rejection notice. Every value keeps its full change history for inspection.
- Rules as constraints. Submission business rules encoded and run against your data on every change.
- Completeness view. Which authorisations are still missing structured data, by product and market.
- Full audit trail. Who changed which data element, when, on what basis, and who approved it.