Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services

By Michiel Stam, MAIN5

After considerable investment in vocabulary standardization and data structuring, pharma companies and marketing authorization holders (MAHs) in the EU should soon get a sense of where compliance with ISO Identification of Medicinal Products (IDMP) standards is leading. That is, we should see the broader benefits of tighter coupling of authorized medicines, product pack, and data carrier IDs with the latest marketing status details, electronic patient information, and product summaries, facilitated by the European Medicines Agency’s (EMA’s) planned rollout of Product Management Services (PMS).

In common with its EU predecessor, the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), PMS will serve as a comprehensive database enabling the consistent and accurate identification of medicines internationally. (It also will support pharmacovigilance and assist in regulatory activities.) The crucial difference is that PMS will manage product data based on IDMP standards, driving greater harmonization as well as richer detail in the information that is registered.

The Clock Is Already Ticking

EMA specifies use of PMS for data enrichment related to critical medicines by the end of 2025 and the end of 2026 for non-critical products (see box below for the latest timeline), meaning there isn’t much time to comply. The agency is already inviting submissions of information on the ingredients and strengths in product compositions based on Module 3 of the registration dossier, rather than on local Summaries of Product Characteristics (SmPCs), which can vary in their terminology. Meantime, submission of data carrier identifiers is supported as of Q2 this year.

EMA PMS is designed to allow for updates and enrichment of existing information, including pack size data, for various purposes such as monitoring drug shortages. So far, much of the data enrichment work to pre-existing authorized product information has needed to be done manually via EMA’s Product Lifecycle Management (PLM) Portal. Once EMA has established a fully operational application interface (API), registered industry and network users will be able to view and edit medicinal product data directly via their own database systems. Currently the API is available in read-only mode, allowing users to view (but not edit) data. EMA is gradually rolling out edit functionality, allowing registered users to modify specific data sets related to non-centralized marketing authorization. (EMA’s implementation guides can be found here.)

Until the full specifications have been finalized, software vendors and the pharma industry remain in limbo to some extent. Yet, as with previous phases of EMA’s IDMP rollout, waiting for concrete requirements is inadvisable; rather, companies should look to progress in any practical way — while retaining the long view.

Setting Sights Beyond Europe

Beyond the EU and Europe more widely (including Switzerland), the national health authorities in the U.S., Brazil, and Canada are among those that have committed to embracing ISO IDMP standards with a view to harmonized global medicines definitions and information exchange. Global harmonization was the original vision for the standards, after all. So, the scale of companies’ compliance capabilities will be critical. To this end, the truer MAHs can be to “pure” ISO standards, the greater their chance of large-scale interoperability, automation, and seamless compliance down the line (as opposed to needing to cater to multiple variations in requirements by region or country).

Interdepartmental collaboration will become increasingly important, too, to realize the full scope of IDMP’s ambitions in promoting harmonization of medicine identification and improved patient safety worldwide. This is more than a regulatory undertaking. Where most IDMP data is currently derived from regulatory source documents as a legacy of document-driven processes (an approach that fulfills most of the needs of EMA Iteration 1), this is not an optimal way forward. Since much of the core data originates in other domains (e.g., R&D, clinical, PV, medical affairs, manufacturing, and supply), ideally data should be managed at the source within the function that generates it.

This will necessitate a companywide effort, with strong cross-functional data governance and technical and semantic interoperability. Ideally, companies should begin with data domains that show visible cross-functional impact. Successes here will showcase what is possible and where tangible value lies.

Moving Beyond Any Immediate Barriers

There are other more technical data challenges, too, beyond the current lack of API connection, the absence of software support, and the lack of a holistic view across product data. These will be resolved in due course but have caused some companies to hesitate until there is more clarity.

For instance, as companies begin to navigate the initial transition to PMS, they are encountering a data mismatch between xEVMPD, SIAMED (EMA's internal database), and evolving PMS data — discrepancies resulting from migration and from pack size splitting, for instance. A general lack of control over data quality and sources is compounding the issue, in addition to the EU centricity of the immediate IDMP implementation.

A lack of current compliance with the FHIR standard (standing for Fast Healthcare Interoperability Resources — designed to facilitate reliable exchanges of healthcare information between different systems) is also presenting complications.

Compounding the situation is the continuing fluidity of requirements. EMA is still refining some of the reference terminology in the controlled vocabularies in the Referentials Management Services (RMS) system, including, for instance, in relation to special precautions for storage and shelf life of materials.

These adjustments, added to system changes, migration, synchronization challenges, and more, further complicate data alignment. Reliance on transitional xEVMPD/SIAMED-based processes and a short-term PMS road map (which lacks a well-defined target operating model) could also cast a shadow as companies attempt strategic planning and effective data enrichment.

Clarity will come soon enough and, with deadlines bearing down, companies’ best strategy is to keep monitoring the evolving EMA guidance while progressing purposefully where they can. That means focusing on and working with the knowns, keeping their sight on the wider picture, and aligning ongoing data preparations as closely as possible with core ISO IDMP parameters. This will ensure they minimize any adjustment work later, positioning them to move swiftly — simply course-correcting as needed — once the finer details have been agreed and published.

About The Author:

Michiel Stam is a management consultant and senior regulatory expert at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. Stam can be reached via email at michiel.stam@main5.de.