European Medicines Agency has announced a regulatory affairs update on modernised XEVMPD / Article 57 user interface (XEVMPDweb), planned for release in Q1 2026.
This upgrade marks a significant step in the digital evolution of EU regulatory data management.

What’s changing?

The new XEVMPDweb replaces the legacy interface with a fully browser-based solution, removing dependencies on outdated components such as ActiveX and IE Tab.
The result: improved accessibility, usability, and long-term system sustainability until switch to PMS full operations.

Key points to note:

• Parallel run: the current and new interfaces will operate side by side for at least three months
• Go-live date: was discussed at SPOR & XEVMPD status update webinar on 28 January 2026
• Early visibility: a draft user manual is already available, enabling MAHs and sponsors to familiarise themselves with the new interface, workflows, and changes

While this upgrade improves usability and removes legacy technical constraints, it does not change the strategic direction of EU regulatory data management.
In the long term XEVMPD will be decommissioned, and Product Management Service (PMS) will become the single authoritative source of product data.

Regulatory outsourcing: how Billev Pharma East Ltd helps you prepare for a PMS-first future and the regulatory strategy

Our focus is not on optimizing XEVMPD for its own sake – we help companies use the remaining XEVMPD lifecycle to get PMS-ready.

• PMS readiness & gap assessment
  We evaluate your current XEVMPD and product data landscape against PMS requirements and expectations.

• Future-proof data strategy
  Design of data structures, governance, and ownership models aligned with PMS as the long-term “source of truth”.

• Controlled transition planning
  Roadmaps that minimize rework and ensure that investments made today remain valid when XEVMPD is decommissioned.

• Process transformation, not patching
  Alignment of regulatory, PV, and data processes with the PMS operating model rather than legacy Article 57 logic.

Are we preparing for the next interface, or for the next regulatory era?

Billev Pharma East regulatory affairs team supports companies that want to be ready for PMS – technically, procedurally, and strategically – before the transition becomes mandatory.

Read more about regulatory updates

The European Medicines Agency (EMA) continues to issue important regulatory updates for its suite of master data platforms that support medicinal product information exchange across the EU and European Economic Area (EEA). These systems—including the Substance Management Service (SMS), Organisation Management Service (OMS), Referentials Management Service (RMS), Product Management Service (PMS) and the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)—are central to harmonising data quality and enabling consistent regulatory procedures. EMA routinely shares progress and plans through quarterly SPOR & XEVMPD status update webinars, ensuring that stakeholders have up-to-date insights on changes and impacts.

The SPOR framework consists of four interlinked services designed to support implementation of the ISO identification of medicinal products (ISO IDMP) standards across regulatory operations. SMS and PMS manage core data for substances and products respectively, while OMS provides validated organisational identifiers and RMS governs controlled referential vocabularies. Together, these services underpin both regulatory submissions and post-authorisation activities by delivering structured and interoperable master data.

A key element in recent regulatory updates has been the ongoing evolution of the Product Management Service (PMS), which is progressively expanding its capabilities to serve both industry and national competent authorities (NCAs). PMS makes structured and standardised human authorised medicinal product data available via a Product User Interface (PUI) and Application Programming Interface (API). Registered users benefit from a consistent source of product master data that can be leveraged across regulatory systems and processes.

In particular, EMA’s planning for 2026 includes a series of targeted releases to enhance the PMS API and PUI functionalities. According to EMA’s roadmap, PMS API development is progressing with phased improvements to enable wider machine-to-machine interactions in line with modern interoperability standards. These changes are intended to facilitate users’ direct access to and submission of product data in formats compatible with broader regulatory infrastructures.

The integration of SPOR services with established regulatory systems—such as IRIS and electronic application forms (eAF)—continues to be a focus of regulatory updates. This integration supports streamlined regulatory action by ensuring that validated master data flows seamlessly into submission systems and decision-making processes. As the SPOR ecosystem evolves, EMA maintains a balance between incremental improvements and stakeholder readiness, with transitional arrangements that allow older and new data services to operate in parallel where needed.

OMS and RMS remain foundational services within this architecture, providing essential reference points for organisational and controlled vocabulary data used across regulatory systems. OMS enriches and standardises legal entity definitions and identifiers, supporting downstream interoperability, while RMS sustains harmonised lists and classifications that are critical for accurate regulatory data capture and reporting. Together, these services enhance consistency and reliability in regulatory workflows.

The annual and quarterly SPOR & XEVMPD status update webinars serve as EMA’s primary forum for sharing regulatory updates on developments across all SPOR components and XEVMPD. These events feature summaries of recent achievements, planned changes and discussions on impacts for industry, authorities and other stakeholders. They also provide opportunities for direct interaction and clarification via Q&A segments and supporting documentation made available on the EMA SPOR portal.

Overall, the ongoing regulatory updates reflect EMA’s commitment to strengthening the EU regulatory data infrastructure. By refining SPOR services, enhancing PMS functionality and maintaining robust interoperability with key telematics systems, EMA supports the consistent management of high-quality regulatory data, thereby facilitating more efficient regulatory assessments and better regulatory outcomes across the European medicines landscape.

Sources: 1 – European Medicines Agency. (n.d.). SPOR and XEVMPD status update webinar, 2 – European Medicines Agency. (n.d.). Substance and product data management services, 3 – European Medicines Agency. (n.d.). Organisation Management Service (OMS), 4 – European Medicines Agency. (n.d.). SPOR (Substance, product, organisation and referential master data), 5 – European Medicines Agency. (n.d.). SPOR Web UI – SPOR data management services.

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