Pharmaceutical organizations, whether global giants or mid-sized companies, are facing a regulatory wave. With the Jordan Food and Drug Administration (JFDA) mandating the submission of electronic product information (ePI) in the Fast Healthcare Interoperability Resources (FHIR) format, the European Medicine Agency (EMA) wrapping up its successful FHIR pilot program, and a growing number of countries signaling their intention to adopt Structured Product Labeling formats, there is one pressing question: How do we modernize our labeling pipelines without ripping everything apart?
Why this matters now
- The EMA’s ePI FHIR pilot has set the stage for imminent adoption of this standard.
- ePI Pharma Ledger and Health Canada’s Structured Product Monograph (SPM) initiatives have put many organizations in catch-up mode.
- Structured health authority submission requirements have raised awareness and interest in pharmaceutical QA, regulatory, tech, and labeling teams about the benefits of scalable FHIR-based ePI and other structured labeling conversions.
In short, companies that move fast now can maintain their competitive edge and implement cost-effective, scalable processes and systems while preserving legacy labeling processes that generate SmPC, PIL, and SPL submissions.
RELATED: Preparing for the Unknown Future of FHIR
Getting Started: Assess the Impact of Structured Content Outputs on your Global Product Portfolio
While the benefits of submitting labels in ePI FHIR format is rightfully receiving much attention, the shift toward structured labeling extends beyond just FHIR. Countries like Turkey and Brazil have begun accepting ePI Pharma Ledger outputs and Health Canada has introduced SPM requirements. Emerging pilots and upcoming mandates are also appearing in Latin America, Asia Pacific, and the Middle East.
So, what happens when a major market like the EMA requires FHIR for all products? Many organizations are beginning to realize:
- Submitting structured outputs in one format or jurisdiction is just the beginning.
- Each format like FHIR, Pharma Ledger, and SPM requires a repeatable, high-quality conversion process.
- Outsourcing conversions, especially at high volumes can quickly become costly and unsustainable.
High conversion volumes do not just mean compliance headaches, vendor selections, and audits. They can strain financial budgets. And these outputs are not going away. Instead, companies should be asking themselves whether they can take advantage of the current window to prepare before structured label submission volumes spike.
Implementing a solution now, while volumes are still manageable, has clear advantages:
- You can develop internal expertise, define processes, and build tribal knowledge before the pressure mounts.
- Internal conversions cost significantly less per document than outsourcing.
- You retain control of the content and speed of your label conversions. Once vendors convert your content, you may rely on them for every update, which could lead to rising costs and reduced flexibility.
Early adopters are using this current runway to build scalable foundations, ensuring that when FHIR becomes mandatory, they are ready to respond with confidence, not chaos.
Picking a Solution: Identify a System That Supports Structured Outputs Today
Once the need is clear, the next step is to identify a system that can deliver. Look for a solution that:
- Can ingest existing labeling content from your regulatory information management system or content repository like Veeva Vault™.
- Can expedite and simplify cut over from unstructured to structured content using artificial intelligence (AI) and natural language processing (NLP) technologies.
- Has proven capabilities to generate structured outputs in global languages like ePI FHIR, Pharma Ledger, and SPM from the same componentized source content.
It is important to choose a system that enhances, rather than replaces, your current processes and systems. For example, your SmPC publishing process may stay the same today, but the new system should allow for ePI FHIR to be generated automatically from the existing documentation.
Future-Proofing Global Labeling: Act Before the Wave Hits
Structured labeling is no longer a distant future. It is underway now, with more markets aligning to global standards like ePI FHIR, Pharma Ledger, and SPM. The companies that are succeeding are not just reacting, they are planning for long-term sustainability.
Rather than building one-off solutions for each new mandate, forward-thinking organizations are investing in modular, scalable systems that work alongside their existing workflows while supporting the future of structured content.
This approach offers:
- Resilience against changing regulatory formats and country-specific nuances
- Continuity for internal teams still producing SmPCs, PILs, and SPLs
- Efficiency through content reuse, automation, and built-in compliance
By implementing a structured labeling engine now, companies can convert early, learn fast, and reduce long-term dependence on vendors that provide conversion services. They can build institutional knowledge, drive cost efficiency, and lead the industry toward a fully digital and patient-friendly future.
At Glemser, we help life sciences organizations prepare for what is next. Our solutions and services are built for compliance, collaboration, and scale.
Let’s talk about how to future-proof your global labeling. Contact Glemser today to get started.