IDMP: structured product data across the regulatory lifecycle

What IDMP requires

IDMP (ISO 11615 series) defines a structured approach to identifying medicinal products — capturing substance, product, organisation and referential data in a form that can be exchanged between regulatory systems globally. Regulatory data exchange shifts over time from document submission to structured product records built around these four core domains.

For regulatory teams, this means internal product data must be governed centrally and submitted in a structured, coded form that remains consistent across the product lifecycle.

• Harmonised CVs — partly

  Dose forms, routes and units are broadly harmonised across authorities. Authorities are aligned on concepts but often diverge on actual term codes.

• Referential CVs — the hard part

  Packaging material type, legal basis, document type and site roles vary significantly by authority — even where meaning is equivalent, the codes differ.

The EU SPOR implementation

EMA's SPOR programme is the EU's operational implementation of IDMP, covering 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 an approach closely mirroring EMA's SPOR model, with a strong emphasis on referential controlled vocabularies:

• IDMP Implementation Guide — outlines structure and requirements for IDMP-compliant submissions
• Controlled Vocabulary — published as a versioned Excel sheet, updated on release cycles
• FHIR APIs — API-first approach for data integration with regulatory systems
• Gov Portal — aspiration to consolidate regulatory interactions into a single Swiss government portal

FDA and IDMP

FDA is IDMP-aligned in parts but not structured as a single SPOR-style programme. GSRS provides an IDMP-compliant substance dictionary, while SPL and NDC broadly align with IDMP product concepts. There is no single Product Master or Organisation Master, and referential vocabularies are not yet harmonised with WHO/EDQM standards.

As PhPIDs are adopted by WHO, FDA's future IDMP-related roadmap is 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 cross-standard mappings
• Product Master Layer — a clearer FDA-wide medicinal product service linking substance (GSRS), product, organisation, packaging 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 intersect across product-level data elements, lifecycle statuses, submission metadata and referential concepts. Examples include Pharmaceutical Dose Form, Route of Administration, Document Type, Site Role and Product Status CVs.

Some authorities — EMA in particular — have embedded IDMP data points (Organisation IDs, Substance IDs, Pharmaceutical Dose Form) directly into their eCTD CV structures. Others, like FDA, have historically kept these separate but will need cross-references as IDMP-aligned data structures are adopted.

Without harmonisation, organisations risk parallel configuration, conflicting code usage and manual reconciliation during submission build.

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.