Ask anyone working across regulatory affairs, pharmacovigilance, or clinical data management for the same question — “which system holds the real, current version of this product’s data?” — and a few years ago, you’d have gotten several different answers depending on who you asked. That inconsistency is exactly what ISO IDMP was built to solve.
The global standardization of information exchange regarding medicinal products is crucial to ensure consistent regulatory compliance, enhance patient safety, and facilitate seamless collaboration across global markets.
The 5 standards cover substances -:
- Dosage forms
- Administration routes
- Presentation units, packaging
- Units of measurement
- Regulated pharmaceutical product information
- Regulated medicinal product information.
Indeed, the adoption of these standards is also expected to enhance operations about clinical trials, regulatory submissions to authorities, and pharmacovigilance services(PV).
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Explore EU Regulatory Services →What Are ISO IDMP Standards?
ISO IDMP standards provide a structured framework for identifying and exchanging medicinal product information, helping regulators and pharmaceutical companies maintain consistent, interoperable product data across regulatory and pharmacovigilance systems. In Europe, EMA’s SPOR and Product Management Service (PMS) are central to the implementation of these standards.
Five ISO IDMP Standards
ISO Standard | Focus |
ISO 11238 | Substances |
ISO 11239 | Pharmaceutical dose forms, units of presentation, routes of administration and packaging |
ISO 11240 | Units of measurement |
ISO 11615 | Regulated medicinal product information |
ISO 11616 | Regulated pharmaceutical product information |
Transitioning from XEVMPD to ISO IDMP Standards
The eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) supports PV activities in the EU and provides an updated and comprehensive repository of medicinal products of the EU. This in turn supports the EudraVigilance system’s efficiency in identifying safety signals and assessing time in a timely manner. However, global standardization is still required which is being achieved through ISO IDMP. EMA has moved all its data from XEVMPD to PMS as per ISO IDMP standards, covering nationally and centrally authorized products. Marketing Authorization Holders (MAHs) should review the PMS for their medicinal products and share any missing data that may be required by National Competent Authorities (NCAs). However, another obstacle is that of duplicate information in various systems that may not be entirely integrated into the new systems.
MAHs will soon need to ramp up their efforts in enhancing data for their medicinal products that are national and centrally authorized. They should also review and evaluate their internal processes to find areas for improvement related to efficiency. Data cleansing is the need of the hour for quality, regulatory compliance and most importantly, patient safety.
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Explore EU Medical Device Regulatory Services →EMA SPOR Programme: The Foundation of IDMP Compliance
What Is EMA SPOR? EMA SPOR is the framework It helps to think of SPOR less as a single system and more as four interlocking pillars (SMS), (PMS), (OMS), and (RMS)., each responsible for one category of master data that everything else in EU regulatory services operations eventually references back to.
- Substance Management Service (SMS) — establishes harmonised, unique identifiers for the ingredients and materials that make up a medicinal product. Without agreement at the substance level, nothing built on top of it (product records, safety signals, dosage information) can stay consistent.
- Product Management Service (PMS) — the operational core for most MAHs day to day. It holds structured product data for both centrally authorised products (CAPs) and non-CAPs and increasingly feeds directly into EMA-facing tools like ePI, eAF, and the IRIS Portal.
- Organisations Management Service (OMS) — maintains a single, validated source of organisation data — names, addresses, and identifiers for MAHs, sponsors, manufacturers, and regulatory authorities — so the same organisation isn’t represented five different ways across five different systems.
- Referentials Management Service (RMS) — supplies the standardised controlled vocabulary and reference terms (routes of administration, units of measurement, and similar coded values) that keep terminology consistent across all the other services.
None of these services were switched on at once. EMA rolled them out in a deliberately staggered order — RMS and OMS first, back in June 2017, with SMS and PMS following in subsequent phases — precisely because product and substance data depend on having stable organisational and reference data already in place underneath them. Understanding that sequencing matters, because it explains why some parts of SPOR feel mature and well-documented today while others (SMS in particular) are still catching up in terms of user-facing functionality.
ISO IDMP vs SPOR vs PMS vs XEVMPD: What’s the Difference?
Term | What it is | Role |
ISO IDMP | International standards | Defines how medicinal product data is structured and identified |
SPOR | EMA master-data services | Implements standardized substance, product, organization and reference data |
PMS | EMA Product Management Service | Manages structured medicinal product data |
XEVMPD | EMA medicinal product database | Supports medicinal-product data for pharmacovigilance |
FHIR | Data exchange standard/API framework | Supports machine-readable exchange of structured product data |
Step-by-Step IDMP Implementation Roadmap
There’s no single universal checklist that fits every MAH, since implementation load depends heavily on portfolio size and how fragmented existing data already is. That said, most organisations moving toward compliance tend to work through the same broad sequence:
- Audit existing product data. Pull together everything currently held across XEVMPD, internal regulatory databases, and any legacy systems, and get a realistic picture of how complete and consistent it actually is.
- Map data against ISO IDMP data fields. Compare what you hold to what the five ISO IDMP standards actually require, and flag the gaps — this is usually where duplicate or conflicting records first surface.
- Register and validate organisation data in OMS. Confirm your organisation’s identity, location, and role data is accurately reflected before moving on to product-level work, since PMS entries reference OMS records.
- Review and enrich product data in PMS. Work through both CAP and non-CAP product entries, filling in missing fields and correcting inconsistencies, using the edit functionality EMA has been progressively rolling out since January 2025.
- Cross-check against National Competent Authority (NCA) requirements. Some data expectations vary slightly by member state, so this step catches anything a purely EMA-level review might miss.
- Align internal systems and processes. Update internal regulatory and PV data workflows, so new submissions are captured in ISO IDMP-compatible structure from the outset, rather than needing retrospective correction.
- Monitor deadlines by product category. Track your organisation’s specific compliance dates — ULCM products, non-CAP products, and any future categories EMA adds — since these have historically shifted and are worth revisiting periodically rather than assuming a fixed date.
- Build ongoing data governance. Treat this as a maintenance function, not a one-off project. New products, variations, and organisational changes all need to enter the system already compliant.
ISO IDMP vs XEVMPD: Key Differences and Migration Guidance
XEVMPD was a meaningful step forward when it was introduced, but it was built for a narrower purpose than what ISO IDMP is designed to do — and that difference in scope is really the source of most migration friction.
Aspect | XEVMPD | ISO IDMP |
Primary purpose | EU-specific repository supporting EudraVigilance and PV signal detection | Global standard for uniquely identifying medicinal products across markets |
Scope | Product data relevant to EU pharmacovigilance | Substances, products, dosage forms, packaging, and units — a broader data model |
Data structure | Largely document- and message-based (XEVPRM submission format) | Structured, standardised data fields aligned to ISO 11238, 11239, 11240, 11615, and 11616 |
Interoperability | Primarily EU-internal | Designed for cross-border and cross-system exchange globally |
Submission method | XEVPRM messages | Increasingly FHIR-based APIs via EMA’s PMS and PLM portal |
Current status | Being phased out, running in parallel during transition | Progressively becoming the primary standard for EU product data |
Migration guidance in practice:
- Don’t treat this as a like-for-like data transfer. ISO IDMP fields are more granular than XEVMPD’s, so a straight export/import will leave gaps. Budget time for genuine data enrichment, not just reformatting.
- Expect a parallel-running period. EMA itself is operating XEVMPD/XEVPRM alongside the newer PMS/FHIR pathway during the transition, and most MAHs will need to do the same internally for a time.
- Prioritize by the deadline category. Given the current ULCM and non-CAP timelines, it makes sense to migrate and validate critical-medicine data first, rather than working through a product portfolio alphabetically or by convenience.
- Reconcile duplicates before migrating, not after. Moving duplicate or conflicting records into the new system just relocates the problem — resolving them in the source data first saves rework later.
- Assign clear internal ownership. Migration tends to stall when it’s treated as “everyone’s responsibility.” A named data owner, even on a small team, keeps the process moving.
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Explore EU Pharmacovigilance Services →Where Things Stand Now: The 2025–2026 Shift
A lot has moved since this piece first went live, and it’s worth pausing to walk through what’s changed on the ground — because “phased implementation” has gone from a roadmap slide to something MAHs are now living through in real time.
- Extended, but firmer, deadlines: Following EMA’s SPOR status update, the Agency pushed out revised timelines for MAHs to get their product data compliant. Critical medicines sitting on the Union List of Critical Medicines (ULCM) now have until June 2026, while non-centrally authorised (non-CAP) products carry deadlines stretching into December 2026 and June 2027. The extension buys organisations breathing room, but it also signals that EMA expects the data submitted this time to be genuinely clean — not a rushed placeholder.
- The June 2026 deadline for enrichment of structured manufacturer data and pack sizes for non-centrally authorised products on the Union List of Critical Medicines has now passed. The remaining milestones include December 2026 for structured manufacturer data for other non-CAPs and June 2027 for pack-size enrichment for other non-CAPs.
- The Public PMS API is finally arriving: One of the more practical shifts: EMA is preparing to release the Public Product Management Service API, with a User Acceptance Testing phase that ran through February 2026 ahead of a planned release around the end of Q1 2026. The Public PMS API is now available in beta. EMA released the beta version on 12 June 2026, allowing structured, machine-readable access to PMS data. A final API version is planned for early 2027. In plain terms, this means registered industry and network users will be able to view — and increasingly edit — ISO IDMP-compliant product data (both centrally and non-centrally authorised products) directly, rather than working through disconnected legacy interfaces.
- A move away from documents, toward data streams: Perhaps the more fundamental change is philosophical as much as technical. EMA’s target operating model is shifting from document-centric submissions toward structured, standardized data flows. Electronic application forms (eAFs) are being rebuilt to align with IDMP fields, and the old XEVMPD/XEVPRM submission pathway is progressively being replaced by FHIR-based APIs, accessible through EMA’s newer Product Lifecycle Management (PLM) portal — which now hosts both the PMS and the updated eAFs in one place.
- Why this matters for pharmacovigilance specifically: Cleaner, standardized product identification data feeds directly into signal detection and safety reporting. When a product’s substance, dosage form, and packaging data are consistently structured across systems, EudraVigilance and equivalent safety databases can match adverse event reports to the correct product with far less ambiguity — which is precisely the kind of friction pharmacovigilance teams have been dealing with for years under fragmented legacy formats.
- The practical catch: None of this is a clean cutover; EMA is running old and new systems in parallel during the transition, which means many organisations are, for now, maintaining data in more than one format at once. It’s an added burden in the short term, but it’s also the reason that getting ahead of data cleansing now — rather than waiting for a deadline to force the issue puts a company in a considerably better position than scrambling later.
ISO IDMP Deadlines and 2026–2027 EMA Milestones
Milestone | Deadline / Status |
SMS initial rollout | 2019 |
PMS edit functionality | From 31 January 2025 |
Public PMS API beta | Released 12 June 2026 |
ULCM non-CAP manufacturer + pack-size enrichment | June 2026 — deadline reached |
Other non-CAP manufacturer data | December 2026 — upcoming |
Other non-CAP pack-size enrichment | June 2027 — upcoming |
Final public PMS API | Planned early 2027 |
XEVMPD/XEVPRM → PMS / ISO IDMP-FHIR transition | Ongoing, phased |
Source of Information: https://www.ema.europa.eu
Conclusion
Global standardization of information pertaining to medicinal products through IDMP Standards is a significant step towards enhancing regulatory compliance, patient safety, and overall operational efficiency within the pharmaceutical industry. EMA being the leader of this transformation begins initiatives, like SPOR and transition to PMS. However, this highlights the efforts required by other stakeholders, like MAHs, in contributing towards refining data and scrutinizing internal processes. Not only will this collaborative effort ensure adherence to regulatory expectations, but it will also help meet the objective of improving global healthcare through more efficient and accurate exchange of information.
With deadlines for ULCM and non-CAP products now firmly in view, and EMA’s Public PMS API opening the door to more direct engagement with structured product data, the window for MAHs to treat ISO IDMP as a distant compliance milestone has closed. The organisations that will move through 2026 and 2027 with the least friction are the ones already treating data quality as an ongoing discipline, not a deadline-driven scramble.
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Frequently Asked Questions
Medicines on the Union List of Critical Medicines (ULCM) now have until June 2026 to meet ISO IDMP compliance requirements under EMA's revised timeline.
Non-centrally authorised products (non-CAP) have staggered deadlines of December 2026 and June 2027, depending on the specific data requirements involved.
The Public Product Management Service (PMS) API allows registered industry and network users to directly view — and in some cases edit — ISO IDMP-compliant product data. A User Acceptance Testing phase ran through February 2026, ahead of a planned release around the end of Q1 2026, making it easier for MAHs to interact with structured product data without relying on older, disconnected interfaces.
XEVMPD (and its submission format, XEVPRM) is being phased out gradually rather than switched off overnight. EMA is running legacy and new systems in parallel during the transition, with FHIR-based APIs and the newer Product Lifecycle Management (PLM) portal progressively taking over data submission and maintenance.
Standardised, structured product identification data makes it easier for systems like EudraVigilance to accurately match adverse event reports to the correct product. This reduces ambiguity in signal detection and supports faster, more reliable safety assessments.