What is IDMP? The five ISO standards for medicines explained
IDMP means Identification of Medicinal Products. Learn what its five ISO standards cover and how EU implementation through SPOR affects regulatory teams.
What is IDMP?
IDMP stands for Identification of Medicinal Products. It is a set of five ISO standards for identifying and describing medicines with shared definitions, so regulators and pharmaceutical companies can exchange product information reliably, as EMA explains.
In pharma, IDMP is a standards framework, not a software package or a single database. EMA describes its use for human medicines across the product lifecycle, including products in development, investigational products, products under evaluation and authorised products. Pharmacovigilance is an expected benefit of those shared definitions.
What the five IDMP standards cover
Each standard covers a different slice of the medicine record. EMA lists these five standards and their subjects:
| Standard | Subject |
|---|---|
| ISO 11615 | Regulated medicinal product information |
| ISO 11616 | Regulated pharmaceutical product information |
| ISO 11238 | Substances |
| ISO 11239 | Pharmaceutical dose forms, units of presentation, routes of administration and packaging |
| ISO 11240 | Units of measurement |
"Medicinal product" and "pharmaceutical product" are separate subjects in that table, so keep the split when you map a product record.
What is the IDMP data model?
The IDMP data model is a structured way to represent those connected categories. It is not a sixth standard or a particular vendor's schema. Covered details include the product name, ingredient substances, strength, route of administration, marketing authorisation, clinical particulars, packaging, and manufacturing, as the same EMA overview sets out.
A regulatory team's practical job is consistent product data. A medicine record needs shared definitions for its ingredients, dose form and units, rather than descriptions that two systems will read differently. EMA also names reuse of information in regulatory submissions as an expected benefit.
How IDMP relates to SPOR in the EU
IDMP describes the standards. SPOR is EMA's master-data framework for the phased EU implementation. The name means substance, product, organisation and referential master data. EMA's four services cover different records:
- SMS identifies the ingredients and materials that constitute a medicinal product.
- PMS manages data for a human medicinal product.
- OMS provides organisation names and location addresses.
- RMS provides controlled vocabularies, such as dosage forms, units of measurement and routes of administration.
EMA's implementation page describes services that are already running. PMS already provides a subset of authorised-product IDMP data through a user interface and an API, while the public API remains a beta and later releases are still expanding the fields that service covers. Because the covered fields still change, use that page for the current scope.
Human and veterinary medicines share SMS, OMS and RMS, but that implementation page applies to human medicines only. These pages do not establish a veterinary PMS obligation.
Has IDMP replaced xEVMPD?
Not completely.
xEVMPD is the Extended EudraVigilance Medicinal Product Dictionary. XEVPRM is the Extended EudraVigilance Product Report Message, the submission format rather than the database. PMS is EMA's product master-data service.
EMA's implementation guidance describes systems operating in parallel and still directs certain pack-size submissions through xEVMPD. It says PMS will fulfil Article 57 requirements once fully implemented. A reference to IDMP does not mean every existing submission route has ended.
What IDMP means for regulatory affairs
EMA attributes an obligation to use ISO IDMP standards to EU Member States, marketing authorisation holders and EMA. It cites Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012.
Separately, holders of marketing authorisations for human medicines in the EU/EEA must submit information on those authorised medicines and keep it up to date under Article 57. The inventory includes medicines authorised centrally and medicines authorised nationally. That existing duty is not the same thing as every IDMP implementation phase being finished.
For IDMP data management, check the EMA guidance that matches your products and fields. Don't treat IDMP compliance as one shared deadline. And this EU implementation does not establish a US or UK obligation.
RegAffairs AI's answer to "What is IDMP in pharma?" introduces the standards. EMA's current implementation page is where the EU service scope is defined.