Data with destiny

As Europe’s adoption of the IDMP data model advances, EMA’s centralised Product Management Services (PMS) platform is coming sharply into focus: with some important deadlines looming from the end of 2025.

So how well positioned is the industry to comply with the associated requirements, and what should companies be doing now? MAIN5’s Michiel Stam assesses their readiness.

The wider benefits of the ISO Identification of Medicinal Products (IDMP) standards should start to take form next year, in Europe at least, facilitated by EMA’s planned rollout of Product Management Services (PMS).

After painstaking investment in vocabulary standardisation and data structuring, pharma companies and marketing authorisation holders in the EU will get a sense of where it is all leading. This includes the tighter coupling of authorised medicines, product pack and data carrier IDs with the latest marketing status details, electronic patient information and product summaries.

Like its predecessor, the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), PMS will form a comprehensive database enabling the consistent and accurate identification of medicines internationally as well as supporting pharmacovigilance and assisting in regulatory activities. But in this case, it will manage product data based on IDMP standards, driving greater harmonisation and richer detail in the information registered.

There is no choice but to prepare for PMS in EU markets, despite a number of persisting challenges. So, what is pharma’s best strategy over the coming months?

Current timescales from EMA specify use of PMS for data enrichment related to critical medicines by the end of 2025, and the end of 2026 for non-critical product, so there isn’t long to prepare.

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 characteristic (SmPCs), which can vary in their terminology. Submission of data carrier identifiers is supported as of Q2 this year, meanwhile.

To date, much of the data enrichment work to existing submissions has had to be done manually though, 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-centralised marketing authorisation.

Until the full specifications have been finalised, 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.

The scale of companies’ compliance capabilities will be critical. Beyond the EU and Europe more widely (including Switzerland), the national health authorities in the US, Brazil and Canada are among those that have committed to embracing ISO IDMP standards with a view to harmonised global medicines definitions and information exchange.

Global harmonisation was the original vision for the standards, after all. The closer MAHs can stay to pure ISO standards, then, the better their chance of large-scale interoperability, automation and seamless compliance down the line, versus having to cater for multiple variations in requirements by region or country.

Interdepartmental collaboration will become increasingly important too, to realise the full scope of IDMP’s ambitions in promoting harmonisation 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 fulfils 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 points to a company-wide effort, with strong cross-functional data governance, and technical and semantic interoperability. A recommended approach is to start with data domains that show visible cross-functional impact. These successes will highlight what is possible, and where tangible value lies.

There are other, more technical data challenges too, beyond the current lack of API connection, the absence of software support and of a holistic view across product data.

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 perpetual movement of requirements. EMA is still updating some of the reference terminology in the controlled vocabularies in the Referentials Management Services (RMS) system, for example, around special precautions for storage and shelf life for materials.

These incremental tweaks, on top of system changes, migration and synchronisation challenges and more, further complicate data alignment. Reliance on transitional xEVMPD/SIAMED-based processes and a short-term PMS roadmap (which lacks a defined ‘To-Be’ target operating model) could also cast a shadow as companies attempt strategic planning and effective data enrichment.

The reality for now is that the pharma industry must look to do all it can and strive to balance the strategic with the tactical as it plans its next steps.