Europe’s rollout of ISO IDMP product data standards is well underway now, and EMA’s aligned Product Management Services (PMS) platform, now live, is the next priority - with deadlines for enriching existing data hitting from the end of this year. MAIN5’s Michiel Stam walks though the emerging implications for pharma companies.
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The rewards for investments in compliance with the ISO Identification of Medicinal Products (IDMP) data standards will start to come into view soon, in Europe at least – enabled by EMA’s planned rollout of Product Management Services (PMS). All of the extensive (and ongoing) foundational work on vocabulary standardisation and data structuring should start to make sense to pharma companies and EU marketing authorisation holders, as they glimpse the eventual impact of tighter coupling of authorised medicines, product pack and data carrier IDs with the latest marketing status details, electronic patient information and product summaries.
As with its predecessor, the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), EMA PMS will serve as a comprehensive, centralised database which supports the consistent and accurate identification of medicines internationally; in addition to pharmacovigilance and more streamlined regulatory activities. But in the case of PMS, product data will be based on IDMP standards, driving greater harmonisation and richer detail in the information registered.
There is no choice but to ready for PMS in EU markets, despite a number of persisting challenges. So what is pharma’s best strategy over the coming months, particularly as companies review and look to align and enrich product data that has already been registered.
Where are we now?
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 products (see box for EMA’s timeline), 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 datasets related to non-centralised marketing authorisation. (EMA’s implementation guides can be found here.)
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.
Looking beyond Europe, and outside of the Regulatory function
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 remain conformant with the global 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).
Inter-departmental 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.
Immediate barriers to tackle
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 potential data mismatches between xEVMPD, SIAMED (EMA's internal database), and evolving PMS data – discrepancies which may result 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.
With so much to do and initial deadlines bearing down, a “wait and see” approach is not an option. Despite some loose ends that still need to be tied up in terms of data preparation specifics, pharma organisations must press on wherever it can (adapting as required), of they are to stay ahead of the additional demands and derive the fuller gains from EU IDMP/PMS compliance over time.