EMEA–EFPIA Product Information Management Initiative

The Burden of Paper-Based Regulatory Submissions

By the late 1990s, pharmaceutical regulatory submissions in Europe were built almost entirely on word-processed documents. Product information — comprising the SmPC, labelling text, and patient package leaflet (PIL) — was created in isolation, often duplicated across departments, and exchanged with regulatory authorities as paper or static electronic files. Any variation to an approved product required re-generating and re-submitting the full text, with all the associated risks of inconsistency, manual error, and version divergence across Member States.

For major pharmaceutical companies with large portfolios, maintaining consistent, current product information across the 15 (and later 25+) EU Member States was a significant operational burden. Translated versions frequently lagged behind approved English-language updates.

Regulatory Agency Capacity Constraints

The EMEA was simultaneously managing a growing workload of new active substance applications, post-authorisation variations, and renewals. Reviewing thousands of pages of product information submitted as unstructured Word documents was slow, labour-intensive, and prone to error. There was a recognised need for a system in which the regulator could receive, validate, and process product information as structured data.

Parallel US Developments & The Promise of XML

The US FDA was pursuing its own Structured Product Labeling (SPL) initiative — an HL7-approved XML standard. The existence of this parallel US initiative reinforced European momentum for PIM and encouraged global companies to consider interoperability between SPL and PIM. Simultaneously, the late 1990s saw significant enthusiasm for XML as a transformative technology, offering the ability to separate content from format, enable dynamic reuse, and support automated processing.

PIM was formally defined as a project to increase the efficiency of the management and exchange of product information through the structuring of information and its exchange by electronic means. Core scope covered three principal product information documents: SmPC, Package Leaflet (PIL), and outer/inner labelling.

Industry Goals

• Eliminate the need to provide paper or Word documents as part of regulatory submissions
• Enable faster, less error-prone submission preparation through XML-enabled authoring tools
• Allow authors to focus on content rather than formatting and layout
• Simplify variation responses — amend XML and resubmit, not produce new Word documents
• Enable local affiliate translation via web-based tools, reducing cycle time and error rates
• Support global harmonisation with the US SPL standard

Regulatory Goals

• Receive product information as machine-readable structured data rather than static documents
• Automate validation of submissions against defined XML schemas
• Support programmatic comparison of proposed and current text during variation assessments
• Improve consistency checking across product information for a given medicine
• Build a structured repository of authorised product information

Governance

PIM was structured as a joint initiative co-led by the EMEA and EFPIA, with a PIM Steering Committee providing strategic oversight and working groups handling technical domains. The technical core was the Document Exchange Standard (DES) — an XML schema defining which data elements were required, optional, or conditional, and how they were to be tagged and validated.

The Light Authoring Tool (LAT)

To support adoption, the EMEA developed a Java-based web authoring tool — the Light Authoring Tool (LAT) — first released in early 2006. It provided basic functionality for viewing, editing, and managing PIM XML files without requiring companies to invest in bespoke XML infrastructure. However, it was never fully integrated with the broader regulatory authoring ecosystem.

• Working XML Standard: The DES represented the first substantive effort to model SmPC, labelling, and PIL as machine-readable data, laying foundations that informed subsequent ePI standards (including the FHIR-based EU ePI Common Standard).
• Successful Pilot Submissions: GSK completed a full NAS submission. Genzyme and Merck Serono used PIM for post-authorisation variations — demonstrating that XML-structured product information could be created, submitted, received, and reviewed within live regulatory procedures.
• Industry Knowledge Building: A substantial body of XML authoring expertise was cultivated across companies like Organon, Genzyme, GSK, and Merck Serono. Training, seminars, and specialist consulting services emerged around PIM.
• Conceptual Framework for ePI: PIM created a generation of regulatory informatics professionals who carried its arguments forward into the modern ePI initiative.

EFPIA member companies broadly supported PIM's objectives — the efficiency arguments around variation management and multi-country translations resonated strongly. However, support was conditional on a workable standard and clear implementation pathway. In practice, many companies felt that the pilot period lasted too long without progressing toward an implementation mandate.

The EMEA invested significantly but was simultaneously managing EU-25/27 expansion, eCTD implementation, and growing pharmacovigilance obligations. PIM competed with multiple other priorities for scarce resource.

• No Regulatory Mandate. PIM operated on a voluntary, opt-in basis throughout. Companies that chose to adopt it bore all transformation costs; those that did not faced no penalty. Without a compliance signal, broad adoption was structurally impossible.
• Legislative Ambiguity. EU pharmaceutical legislation at the time was written around paper and document-based paradigms. Any move to mandatory structured submission would have required legislative amendment — which was never forthcoming.
• Technical Complexity & Tooling Limitations. The LAT was functional but not integrated with the broader regulatory authoring ecosystem. The standard went through multiple revisions, creating uncertainty for companies considering investment in custom PIM solutions.
• EMEA Strategic Reprioritisation. The formal closure announcement stated explicitly that the EMA was undertaking a review of its business strategy and IT requirements in the context of new legislation and a budgetary review. PIM lost the internal sponsorship contest.
• Scope Limited to Centralised Products. The majority of EU-authorised medicines are approved nationally, via MRP or DCP. Companies with mixed portfolios would need two parallel processes — reducing the efficiency case substantially.
• Double-Running Burden. The EMEA continued to request Word documents alongside PIM XML during the pilot, meaning companies bore the cost of producing both formats without eliminating the traditional workflow.
• ROI Uncertainty. With no compliance deadline, the investment case rarely favoured proactive adoption — particularly while eCTD implementation was simultaneously demanding significant regulatory IT resource.

PIM was withdrawn in 2011, but the EMEA explicitly stated its commitment to returning to structured product information once its strategic review was complete. The decade between PIM's closure and the launch of the modern ePI pilot saw important evolution: proliferation of smartphones created new consumer pull for electronic medicines information; HL7 FHIR emerged as a more broadly supported standard than proprietary XML schemas; and the COVID-19 pandemic dramatically accelerated regulatory digitalisation.

The EU ePI initiative, formally piloted from 2023 with EMA, HMA, and European Commission participation and backed by EU4Health funding, addresses many of the structural failures that limited PIM. It uses FHIR-based standards with broader interoperability potential; it has explicit Commission-level support; it is aligned with the revised EU pharmaceutical legislation; and it includes nationally authorised products within its scope.

The EMEA-EFPIA PIM initiative achieved real technical milestones — a functioning XML standard, a working authoring tool, live pilot submissions — but ultimately could not cross the threshold from structured pilot to systemic implementation. Its failure was not a failure of conception or technical execution; the core thesis that EU regulatory product information should be machine-readable, structured, and lifecycle-managed was correct then and remains correct today.

PIM's inability to achieve full implementation reflects a recurring pattern in large-scale, cross-stakeholder digital transformation programmes: voluntary adoption cannot substitute for a regulatory mandate; partial scope creates fragmented value propositions; resource competition within agencies constrains sustained investment; and the cultural distance between established practice and new technology is routinely underestimated.

For pharmaceutical companies and their advisers, PIM's history is a reminder that first-mover investment in transformational regulatory technology carries significant risk when the underpinning policy infrastructure is absent — and that the window for mandatory adoption can remain closed for a surprisingly long time.

The legislative mandate secured by ePI eliminates the primary structural failure that doomed PIM. But a mandate is not the same as successful implementation. The following recommendations draw directly on PIM's history.

1. 1

   Hold the Implementation Timeline

   Publish and adhere to a non-negotiable timetable. PIM's timelines slipped continuously — EFPIA's Co-Chair publicly noted in 2009 that "timelines have slipped slightly," understating years of deferral. Timeline slippage destroys industry investment confidence.

2. 2

   Eliminate Double-Running from Day One

   Formally commit that companies submitting valid ePI will not be required to produce parallel Word documents. The moment a company submits FHIR-based ePI, the Word requirement should cease for that procedure.

3. 3

   Invest in Industrial-Grade Authoring Infrastructure

   Publish open FHIR API specifications early enough to allow vendors (Veeva Vault, IQVIA, OpenText) to develop compliant integrations before the mandatory adoption date.

4. 4

   Extend Scope to Nationally Authorised Products Concurrently

   PIM's confinement to the centralised procedure meant the majority of EU medicines were permanently outside its scope. ePI's multi-procedure pilot scope must be preserved in the implementation roadmap.

5. 5

   Build FHIR-Native Review Tooling for Regulators

   Invest in assessor tools that enable programmatic comparison of proposed and current ePI text. PIM's efficiency gains for regulators were constrained by the absence of XML-capable review infrastructure on the regulatory side.

6. 6

   Provide Credible Legacy Content Migration

   The Word-to-FHIR conversion tool demonstrated in 2024 was assessed by EFPIA's IATF as insufficiently mature. This must be developed to production quality before the mandatory phase. PIM offered no conversion pathway; companies had to re-author from scratch.

7. 7

   Build Skills Across All Company Sizes

   PIM's adoption was confined to a small cohort of well-resourced innovator companies. The generics sector — responsible for the majority of EU prescriptions — must be enabled and supported, not just obligated.

8. 8

   Maintain Consistent Senior Sponsorship

   PIM ultimately lost the internal sponsorship contest. ePI now has legislative anchoring — but legislative mandates can be delayed in implementation. Sustained, visible senior leadership is a precondition for holding the implementation on schedule.

9. 9

   Define and Publish Patient-Facing Success Metrics

   ePI's patient access rationale — consistently cited in Commission and EMA communications — is a genuine differentiator, but only if outcomes are measured and demonstrated. Demonstrating patient benefit is also the most effective mechanism for sustaining political support.

10. 10

    Plan for Long-Term Sustainability

    Include a clear model for how the FHIR standard will be maintained, how the PLM Portal will be funded post-EU4Health, and how the standard will remain aligned with FHIR version updates and international regulatory developments.