IDMP: Products, substances, organisations — and how they connect
A plain-English guide to the core IDMP data domains and their operational implications for pharmaceutical regulatory teams.
What IDMP requires
IDMP (ISO 11615 series) defines a structured approach to identifying medicinal products — capturing substance, product, organisation and referential data in a way that can be exchanged between regulatory systems globally. The focus of regulatory data exchange would shift over time from "documents" to "product records" that are structured around these core data domains and their associated controlled vocabularies.
For regulatory teams, this means internal product data must be governed centrally and made available in a structured, coded form that can be
submitted to authorities and remain consistent across the product lifecycle.
The biggest challenge is often the referential domain. While the health authorities across the gloe are likley to "largely" harmonise the controlled vocabularies for dose forms, routes, units, etc.
The regulatory team would have greater challenge in harmonising the CVs for "Packaging Material type", "Legal basis", "Document type" or "Role of A site/organisation".
Even if controlled terms are similar in meaning and context, their actual "TERM" and associated codes will be specific to each regulator
The EU SPOR implementation
The EMA's SPOR programme (Substances, Products, Organisations and Referentials) is the EU's operational implementation of IDMP. It covers the four master data domains that underpin product lifecycle management across the EU:
- SMS — Substance Management Service: controlled substance identifiers
- PMS — Product Management Service: EU-wide medicinal product records
- OMS — Organisation Management Service: MAH, sponsor and manufacturer identifiers
- RMS — Referential Management Service: the controlled vocabulary backbone (dose forms, routes, units, etc.)
SwissMedic's IDMP implementation
SwissMedic has adopted implementation approach that closely mirrors the EMA's SPOR model, with a strong emphasis on referential controlled vocabularies. Their implementation includes:
- IDMP Guide — Implementation guide that outlines the structure and requirements for IDMP implementation
- Controlled Vocabulary — Controlled vocabulary - published as an Excel sheet
- FHIR APIs — Adopting an "API first" approach for data integration
- Gov Portal — Initial documentation indicate aspirtation to implement a single Swiss Gov portal
FDA and IDMP
FDA has adopted an implementation approach that is IDMP-aligned in parts, but not organised as a single SPOR-style master data programme. GSRS serves as IDMP compliant Substance dictionary, while SPL and NDC provide broad alignment with IDMP product concepts. However, there is no single "Product Master" or "Organisation Master" that fully embeds GSRS codes, and the referential vocabularies are not currently harmonised WHO / EDQM. Drawing on the FDA's published roadmap and public statements,as PhpIDs get adopted by WHO, the FDA's future IDMP-related efforts are likely to focus on:
- SPL modernisation — Transition from document-centric XML toward dual SPL/FHIR and eventually FHIR-first exchange
- Controlled Terminology Services — Versioned, API-based referentials with stronger governance and mappings
- Product Master Layer — A clearer FDA-wide medicinal product service linking substance (GSRS), product, organisation (from NDC), packaging(SPL), and status data
- IDMP Alignment —More explicit mappings between FDA data models and ISO IDMP concepts
Where IDMP and eCTD overlap
eCTD and IDMP controlled vocabularies do not operate independently. They intersect across product-level data elements, lifecycle statuses, submission metadata and referential concepts. The level and degree of overlap will vary by agency, but examples include: "Pharmaceutical Dose Form" CV, "Route of Administration" CV, "Document Type" CV, "Site Role" CV, "Product Status" CV, etc. Some agencies such as EMA have added placeholders for Organisation Ids, Substance ID along with IDMP data points such as "Pharmaceutical Dose Form" in their eCTD CVs, while others such as FDA have historically kept these separate but may need to add cross-references and mappings as IDMP-aligned data structures get adopted.
Without harmonisation, organisations risk parallel configuration, conflicting code usage, and manual reconciliation during submission build. The secure portal provides tooling to surface and manage these overlaps.
IDMP data domains
- Substances — active moieties, salts, excipients
- Products — medicinal product records
- Organisations — MAH, manufacturers, sponsors
- Referentials — dose forms, routes, units, regulatory entitlements
Each domain relies on controlled vocabularies that must align with both internal systems and authority-published code lists.