As Europe’s implementation of ISO IDMP data standards progresses, EMA’s centralised Product Management Services (PMS) platform is emerging as the next priority for the life sciences industry to tackle in earnest. MAIN5’s Michiel Stam unpacks the compliance preparations stretching ahead as the first deadlines approach.
As Europe’s rollout of ISO Identification of Medicinal Products (IDMP) data standards continues, EMA’s centralised Product Management Services (PMS) platform is emerging as the next priority for life sciences organisations to get to grips with. Serving as a comprehensive database for the consistent and accurate identification of medicines internationally, PMS has relevance not only for traditional pharma but also increasingly to mobile devices and healthtech. This is due to its role in standardising data management for medicinal products, including those used in conjunction with devices.
The Product Management Services is aligned with IDMP, and all that these standards promise in facilitating interoperability and data exchange, which will be important for leveraging mHealth tools and real-world data. It paves the way for tighter coupling of authorised medicines, product pack and data carrier IDs with the latest marketing status details, electronic patient information and product summaries, for instance.
PMS is now live in EU markets, despite some initial obstacles around data enrichment and how to achieve this efficiently for established products. So what is pharma’s best strategy over the coming months?
The clock is ticking
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[1].)
Until the full specifications have been finalised, software vendors and the pharma industry remain somewhat in limbo. Yet, as with previous phases of EMA’s IDMP rollout, waiting for concrete requirements is inadvisable given the scope of the work ahead.
Keeping sight of the broader picture (beyond Europe, beyond Reg Affairs)
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.
Facing down temporary obstacles
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 Product Management Services, they are encountering potential data mismatches between the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD – PMS’s predecessor), SIAMED (EMA’s internal database), and evolving PMS data. These discrepancies 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.
Adding to the data alignment complexity are continued revisions to EMA’s exact requirements (e.g. tweaks to reference terminology in the controlled vocabularies. Reliance on transitional xEVMPD/SIAMED-based processes and a short-term PMS roadmap (which lacks a defined ‘To-Be’ Target Operating Model) aren’t helping either. Yet the life sciences industry must press on regardless, and do what it can to stay ahead.
Current PMS (Product Management Services) deadlines:
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Submit information on all packages in xEVMPD: ensure all authorised products are split at pack size level. Deadline: 31 May 2025 for critical medicines; end of 2026 for non-critical medicines.
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Submit package description in xEVMPD: enrich package description for all medicines following EMA’s recommended naming convention. Deadline: 31 May 2025 for critical medicines; end of 2026 for non-critical medicines.
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Submit pack size information in PMS: enrich PMS with structured pack size data. Deadline: by the end of 2025 for critical medicines and the end of 2026 for non-critical medicines.
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Submit manufacturers and manufacturing business operations in PMS: enrich manufacturers and manufacturing business operations data in PMS for non-CAPs. Deadline: by the end of 2025 for critical medicines and the end of 2026 for non-critical medicines.
References
[1] EMA Write PMS API implementation Guide, Version 1 – European Medicines Agency, January 2025: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-write-pms-api-implementation-guide_en.pdf
About the author
Michiel Stam is a management consultant and senior regulatory expert at MAIN5 with 15 years of experience in Regulatory Information Management (RIM) and IDMP. MAIN5 is a European consulting firm specialising in digitally-enabled change for Life Sciences R&D organisations.