The IDMP Standards — Five ISO Standards, One Framework

IDMP — the Identification of Medicinal Products — is a set of five international standards developed by ISO specifically to create one harmonised, structured framework for identifying and describing every key aspect of a medicinal product, addressing exactly the fragmentation problem this module opened with, but with considerably more structural rigor than WHO-DD’s name-linking approach.

Two of the five standards work at genuinely different levels of specificity, and the distinction matters precisely. ISO 11615 defines the Medicinal Product Identification (MPID) — the full, specific, regulated product as authorised in a particular market, essentially the complete regulatory identity of one specific product. ISO 11616 defines the Pharmaceutical Product Identification (PhPID) — a somewhat broader identifier working at the level of active substance, strength, and pharmaceutical dose form, which lets a safety signal be tracked and compared across an entire product class or generic equivalents, not just one single branded product. The PhPID is specifically what DIA’s recent webinar content flagged as central to modern drug-shortage and multi-product signal work — it’s the identifier that lets a reviewer ask "is this a signal affecting this specific brand, or every product containing this active substance at this strength" and actually get a structurally reliable answer.

The remaining three standards define the components underneath both product identifiers. ISO 11238 standardises substance identification — defining substances by their general, main, and specified characteristics, including handling substances that have multiple components. ISO 11239 standardises pharmaceutical dose forms, routes of administration, and packaging — the "how it’s actually taken and packaged" layer. And ISO 11240 standardises units of measurement — without which a strength value like "500" is structurally ambiguous across different systems, since it could mean 500mg, 500mL, or 500 international units depending entirely on which recording system generated it, with nothing in the raw data to disambiguate.

IDMP as a whole is explicitly designed for a more demanding use case than WHO-DD was originally built for: it’s built to support exactly the kind of federated, multi-database, cross-jurisdictional RWE analysis Module 15 covered in depth, where a study needs to reliably identify "this exact product" or "this substance-strength-form combination" consistently across databases, countries, and regulatory systems that were never designed to talk to each other — the same structural challenge OMOP solved for clinical data generally, applied specifically to product identity.