IDMP: Guide to ISO Standards and EMA SPOR

IDMP (Identification of Medicinal Products) is an international suite of five normative standards developed by the International Organization for Standardization (ISO) to uniquely identify and describe medicinal products for human use. These standards establish a harmonized data framework across regulatory authorities, pharmaceutical manufacturers, and healthcare systems to enhance patient safety and regulatory oversight.

Historically, divergent national vocabularies and product registries created data silos that delayed adverse event detection and hindered drug shortage management. IDMP addresses this by defining standardized data elements for substances, pharmaceutical dose forms, units of presentation, routes of administration, and packaging across the product lifecycle.

What it is

The ISO IDMP suite defines the data structures and exchange specifications necessary to describe regulated medicines from discovery through post-authorization surveillance. It comprises five core standards published by ISO Technical Committee ISO/TC 215 in collaboration with global health authorities:

ISO 11615:2017: Defines data elements to uniquely identify marketed and Investigational Medicinal Products (IMPs). It establishes the Medicinal Product Identifier (MPID) for regulatory authorizations and the Package Item Identifier (PCID) for packaged items.
ISO 11616:2017: Defines data elements for the Pharmaceutical Product Identifier (PhPID), an algorithmic identifier grouping products by substance composition, strength, and reference dose form, independent of brand name or manufacturer.
ISO 11238:2018: Standardizes data structures for uniquely identifying active substances, excipients, and adjuvants through a standardized Substance Identifier (SubID).
ISO 11239:2012: Establishes controlled vocabularies for pharmaceutical dose forms, units of presentation, routes of administration, and packaging components.
ISO 11240:2012: Standardizes units of measurement for product strength and quantity, aligning with the Unified Code for Units of Measure (UCUM).

Together with technical specifications such as ISO/TS 20443 (utilizing Fast Healthcare Interoperability Resources, or FHIR) and ISO/TS 19844, these standards establish interoperable regulatory metadata formats.

Who runs it and what it covers

ISO maintains the normative standards, while regional health authorities govern implementation and operational infrastructure within their respective territories.

European Medicines Agency (EMA) and SPOR

In the European Union, IDMP compliance is legally mandated by Commission Implementing Regulation (EU) No 520/2012 (Articles 25 and 26). The EMA implements these standards across member states via the Substance, Product, Organisation and Referential (SPOR) master data services:

Substance Management Services (SMS): Centralizes verified substance definitions (SubIDs) conforming to ISO 11238.
Product Management Services (PMS): Manages authorized medicinal product data conforming to ISO 11615 and ISO 11616, replacing legacy reporting under the eXtended EudraVigilance Product Report Message (XEVPRM).
Organisation Management Services (OMS): Assigns unique identifiers to sponsors, marketing authorization holders, and manufacturing sites.
Referentials Management Services (RMS): Houses controlled vocabularies for dose forms, administration routes, and measurement units conforming to ISO 11239 and ISO 11240.

United States FDA Framework

The US Food and Drug Administration outlined its approach in its final guidance, Identification of Medicinal Products — Implementation and Use (CDER/CBER Docket FDA-2023-D-0266, March 2023). Rather than replacing domestic systems, the FDA integrates IDMP by:

Prefixing the domestic National Drug Code (NDC) with country code “US” to produce ISO-compatible MPID and PCID codes.
Using Unique Ingredient Identifiers (UNII) registered in the Global Substance Registration System (G-SRS) to satisfy ISO 11238 substance rules.
Transmitting product registration data via Structured Product Labeling (SPL) conforming to ISO/TS 20443.

Global Surveillance

At the international level, the WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre) integrates PhPID structures to link global safety data, complementing post-market oversight systems like the pharmacovigilance system master file (PSMF).

How to search or use it

Regulatory professionals and pharmaceutical data managers access IDMP vocabularies and manage product submissions through regional regulatory portals. The standard workflow includes the following seven steps:

Open the Regulatory Referential Portal: Access the public interface of the regulatory master data platform (such as the EMA SPOR Portal at spor.ema.europa.eu or the FDA G-SRS registry). Public searches do not require corporate credentials.
Query Referentials Management Services (RMS): Select the relevant list domain (e.g., “Pharmaceutical Dose Form” or “Route of Administration”). Search by term name to locate the concept identifier and ensure the status is “Current”.
Search Substances in SMS or G-SRS: Input the substance name, CAS number, or UNII to retrieve the authorized Substance Identifier (SubID) and verify molecular details.
Verify Organizational Data in OMS: Search OMS for the Marketing Authorisation Holder or manufacturing site to confirm the valid OrgID and Location ID (LocID).
Construct the 4-Level PhPID: Map the product to the appropriate PhPID tier defined in ISO 11616:
- Level 1 (PhPID_SUB): Substance only.
- Level 2 (PhPID_SUB_STR): Substance and strength.
- Level 3 (PhPID_SUB_FORM): Substance and reference dose form.
- Level 4 (PhPID_SUB_STR_FORM): Substance, strength, and reference dose form.
Build the Product Management Services (PMS) Payload: Compile product trade names, packaging configurations, shelf life, and manufacturer data into an HL7 FHIR-compliant structure conforming to ISO/TS 20443.
Submit and Validate: Upload the structured payload through the regulatory submission portal (such as the EMA Product Lifecycle Management portal or FDA Electronic Submissions Gateway) and confirm receipt against technical validation rules.

Strengths and limits

Strengths

Unambiguous Cross-Border Identification: Separating active composition (PhPID) from commercial packaging (MPID) enables global cross-referencing across diverse trade names.
Accelerated Pharmacovigilance: Standardized substance and product identifiers eliminate naming discrepancies, speeding international safety signal detection.
Shortage Mitigation: Regulators can query equivalent products across borders sharing the identical PhPID Level 4 structure when local supplies fail.
Regulatory Interoperability: Harmonized terms streamline clinical trials and complement regulatory systems such as EUDAMED medical device tracking and clinical trial supply management.

Limits

Implementation Complexity: Pharmaceutical sponsors must update legacy systems across regulatory, clinical, and supply chain functions to align with external master data repositories.
Staggered Regional Timelines: The EU enforces legal mandates through SPOR, whereas the US FDA integrates IDMP incrementally using existing NDC and SPL mechanisms.
Governance Overhead: Regular maintenance is required to synchronize internal records with updated RMS controlled vocabularies and OMS facility changes.

Alternatives

The following table compares ISO IDMP with established legacy and regional drug coding systems:

System / Standard	Primary Scope	Geographic Reach	Key Identifiers	Relationship to IDMP
ISO IDMP Suite	Full medicinal product lifecycle data (substances, packaging, doses)	Global (ISO / WHO / EMA / FDA)	MPID, PCID, PhPID, SubID	Target international standard unifying medicinal product identification across borders.
EU XEVMPD (Article 57)	EU authorized medicinal product database for pharmacovigilance	European Union	EV Code	Legacy EU repository being superseded by EMA SPOR Product Management Services.
US NDC & SPL	US product listing, packaging identifiers, and electronic labeling	United States	NDC (10/11-digit), UNII	Integrated into IDMP by prefixing NDC with “US-” to form compliant MPIDs and PCIDs.
RxNorm (US NLM)	Standardized clinical drug nomenclature for e-prescribing and EHRs	United States	RxCUI	Focuses on domestic clinical healthcare delivery; complementary to IDMP regulatory dossiers.
WHO ATC / DDD	Therapeutic, pharmacological, and chemical drug classification	International	ATC Code	High-level classification system referenced as an attribute within IDMP records.

FAQ

What is the difference between MPID and PhPID in IDMP?

An MPID (Medicinal Product Identifier) identifies a specific, commercially authorized medicinal product from a specific marketing authorization holder within a country. A PhPID (Pharmaceutical Product Identifier) is an algorithmic identifier under ISO 11616 that groups products with identical active substance, strength, and reference dose form, regardless of brand name or manufacturer.

Why is IDMP legally mandated in the European Union?

The European Union mandated IDMP under Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012 to establish a single, robust data exchange mechanism across member states, strengthening pharmacovigilance safety signals, preventing medication errors, and tracking supply chains.

How does the US FDA implement ISO IDMP standards?

Under its March 2023 guidance (Docket FDA-2023-D-0266), the FDA prefixes existing National Drug Codes with “US” to produce ISO-compliant MPIDs and PCIDs, utilizes Structured Product Labeling (SPL) under ISO/TS 20443, and links Unique Ingredient Identifiers (UNII) via the Global Substance Registration System.

What are the four pillars of the EMA SPOR framework?

The EMA SPOR framework consists of four master data services: Substance Management Services (SMS, ISO 11238), Product Management Services (PMS, ISO 11615/11616), Organisation Management Services (OMS, organization and location IDs), and Referentials Management Services (RMS, ISO 11239/11240 controlled terms).

Does IDMP replace existing national drug coding systems like NDC or RxNorm?

No. IDMP acts as an overarching international reference framework. National authorities map existing identifiers into the IDMP data structure, allowing domestic clinical workflows to remain intact while achieving global data interoperability.

Sources

European Medicines Agency (EMA). Data on medicines (ISO IDMP standards): Overview. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview (Checked 2026-11-07).
European Medicines Agency (EMA). Substance, product, organisation and referential (SPOR) master data. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data (Checked 2026-11-07).
European Union. Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities. Articles 25 and 26.
U.S. Food and Drug Administration (FDA). Identification of Medicinal Products — Implementation and Use: Guidance for Industry. Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), March 2023. Docket FDA-2023-D-0266. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/identification-medicinal-products-implementation-and-use (Checked 2026-11-07).
International Organization for Standardization (ISO). ISO 11615:2017, ISO 11616:2017, ISO 11238:2018, ISO 11239:2012, ISO 11240:2012 (Health informatics — Identification of medicinal products).