The current and future implications of the Product Management Service (PMS) are becoming increasingly apparent. A key part of the European Medicines Agency’s (EMA) four-part SPOR master data program, PMS contains detailed structured and validated information on authorized European Economic Area (EEA) medicinal products[1].
As we have previously explored, it is intended to be a single source of truth for medicinal product data. Currently, PMS is limited to the data that was imported by EMA from XEVMPD, but in the longer run it will be extended to encompass a larger share of the Identification of Medicinal Products (IDMP) model, though the full extent is not yet clear[2].
Regardless of what the longer-term implications of the PMS are, preparing for it will be challenging for industry.
Short-term planning
As we have outlined, there are already several activities involving the PMS that are required of industry, for example, to support information for the European Shortages Monitoring Platform (ESMP) for any product on the Union List of Critical Medicines (ULCM)[3].
To prepare for both near-term and other PMS activities, it is advisable for companies to start strategic planning to ensure that data cleansing and additions to XEVMPD are performed efficiently. How they go about this depends on how they handle XEVMPD data submissions – using either EMA’s free EVWEB tool[4] or in-house systems if their XEVMPD data is organized in a regulatory information management (RIM) system or another dedicated tool.
These activities may require additional resources, especially for the XEVMPD cleansing and extension activities, and when taking into account the deadline of February 2025 timeline for some of these activities on ESMP-relevant products [5]. Near-term activities for industry should, therefore, include:
- Reviewing entries for the Organisation Management Services (OMS) for Marketing Authorization Holders (MAHs) and Manufacturers
- Checking SMS (Substance Management Services) data used to describe the composition of products and performing corrections as needed. This also includes checking the substances’ current Substance Validation Group (SVG) assessment status and may require assigning different substance terms to products [6].
- Making sure products have been migrated correctly and completely from XEVMPD to PMS
The PMS product user interface (PUI) was released in 2024, allowing MAHs to view their authorized product data in read-only mode[7]. By now this also includes the nationally authorized products. Once the enrichment function in the PMS PUI has been enabled – which is expected by early 2025 – the structured pack size information and additionally the information on manufacturers should be completed for ULCM products by the end of 2025 and for other products by the end of 2026, as shared by EMA during various sessions. There will also be the option to submit data carrier ID for both centrally authorized as well as non-centrally authorized products using the PUI.
Companies are advised to wait for more information from the national authorities with regards to the data carrier ID, since currently there appears to be a lack of consensus on how this should be addressed. However, there will likely be the potential to reuse the data and have the connections in place for logistics and serialization. Furthermore, the EMA is committed to cooperating with the national competent authorities (NCAs) so they can reuse the data, for example to streamline regulatory processes. At the moment, though, the NCAs’ focus also lies on the ULCM products and the input they have to provide to ESMP. National stock and expected future demand need to be reported by NCAs into the shortages monitoring platform and therefore be aligned and matched with the data on products coming from PMS[8].
Other near-term activities companies will need to commit to include looking into their current XEVMPD data maintenance processes, checking for improvements and, where necessary, allocating additional resources.
Another near-term activity that companies will need to address is the inclusion of any product needed in web-based electronic application forms (such as homoeopathic and herbals).
Longer-term PMS planning
Once the PMS user interface enrichment functionality becomes available in early 2025, companies should consider preparing and performing the first enrichment of PMS data beyond the scope of XEVMPD data. This includes adding structured pack size information and adding manufacturers.
Looking further into the future, companies might consider implementing dedicated software systems to better imbed PMS data handling into their overall database and process landscape, with the potential to also cover non-EU products and activities such as enterprise resource planning (ERP) or labeling and artwork. But the extended scope of data in PMS (compared to XEVMPD) may lead even smaller companies with less complex product portfolios to consider investing in additional or more complex software solutions.
We will continue to keep you informed as new information on the PMS emerges. In the meantime, we would welcome your feedback on how you are progressing with PMS and any questions and concerns you have.
About the author:
Karl-Heinz Loebel is Director and Principal Consultant, Regulatory Operations, at PharmaLex. With more than 19 years of experience in regulatory operations, he has built his expertise in data management and the electronic exchange of information with regulators and has been a constant contributor to shared industry/agency forums on digital data exchange for the past decade.
[1] Substance and product data management services, EMA. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/substance-product-data-management-services#pms-implementation-plan-12044
[2] Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe, EMA. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/substance-product-data-management-services
[3] Commission publishes first Union Critical Medicines list to tackle shortages, European Commission. https://ec.europa.eu/commission/presscorner/detail/en/ip_23_6377
[4] EudraVigilance system overview, EMA. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-system-overview#:~:text=The%20EudraVigilance%20web%20application%20(EVWEB,enables%20users%20to%20perform%20queries.
[5] European Shortages Monitoring Platform (ESMP) Essentials and Industry Reporting Requirements Webinar, EMA, June 2024. https://www.ema.europa.eu/system/files/documents/presentation/20240624_esmp-essentials-industry-reporting-requirements_v1_en.pdf
[6] HMA Substance Validation Group, Heads of Medicines Agencies (HMA). https://www.hma.eu/about-hma/working-groups/hma/hma-substances-validation-group.html
[7] PMS – News Articles, Product Lifecycle Management Portal, European Union. https://plm-portal.ema.europa.eu/Guidance/article/KA-01031/en-us/
[8] European Shortages Monitoring Platform (ESMP) Implementation Guide for National Competent Authorities, Version 1.0, 24.07.2024, EMA. https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-implementation-guide-national-competent-authorities_en.pdf
