Master Data Models & Conformance
Deterministic data structures aligning pharmaceutical substances, organisations, referentials, and medicinal products across global health authorities.
Data elements and structures for unique identification of authorised medicines.
PhPID construction based on substances, dose forms, and strengths.
Scientific definition and structural taxonomy of biologicals & chemicals.
Harmonised terms for routes, packaging, and presentation units.
Universal mapping conforming to UCUM international standards.
SPOR Data Model & FHIR Payload Inspector
Select a SPOR pillar below to inspect the master data schema, field taxonomy, and JSON FHIR structure.
Substance Management Services
Defines scientifically validated identifiers for chemical substances, biologicals, polymers, and herbal materials.
{
"resourceType": "SubstanceDefinition",
"id": "SUB-1000948-EMA",
"identifier": [{
"system": "https://spor.ema.europa.eu/v1/sms",
"value": "1000948"
}],
"status": {
"coding": [{
"system": "https://spor.ema.europa.eu/v1/rms",
"code": "100000000004",
"display": "Active"
}]
},
"classification": [{
"coding": [{
"code": "Biological",
"display": "Specified Substance Group 1"
}]
}]
}Need help migrating your legacy dossiers to ISO IDMP?
Our regulatory data engineers can ingest your existing eCTD Module 1 and 3 dossiers and generate clean, validated SPOR submissions.