Making the Transition to Electronic Product Information (ePI)

 Across the pharmaceutical industry, many regulatory agencies are pushing for a transition to Electronic Product Information (ePI). But what exactly is ePI, and why is this transition happening?

Electronic Product Information, or ePI, refers to a digital version of product labeling that patients and healthcare professionals rely on every day. Things like dosage, administration, side effects, and storage instructions. The push for ePI is about more than going paperless. Health authorities across the globe are championing this shift to ensure that accurate, up-to-date information is easier to access, search, and understand, especially for patients and caregivers. By digitizing the information, ePI enables faster updates, reduces the risk of outdated materials being used in care decisions, and supports translations into multiple languages and accessible formats. Ultimately, it’s about empowering safer, more informed use of medicines.

Two of the largest health authorities, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are making significant strides to implement ePI.

1. The EMA has launched a multi-year initiative to implement ePI across the EU, aiming to provide patients with real-time access to reliable, readable information in their preferred language.
2. The FDA is exploring digital labeling solutions through pilot programs to modernize how labeling is distributed and used in clinical settings.

In short, ePI represents a major step toward a faster, more automated, and more accessible future for medicinal product information.

What Are the Challenges of Transitioning to ePI?

Understanding ePI and its value is just the beginning. Implementing it at scale comes with a range of challenges, including:

1. Regulatory compliance
   Generating data according to detailed and evolving requirements is a complex task. It becomes even more challenging with regional variations and language needs. These requirements may be updated at any time, requiring organizations to revise large volumes of existing labeling content.
2. Technology limitations
   Legacy systems used to generate labeling content today were not designed for structured content authoring. Implementing modern tools that meet security and privacy standards can be both time-consuming and costly.
3. Operational change
   New formats and systems introduce new procedures. Training teams, managing resources, and adjusting workflows to handle fluctuating regulatory expectations add layers of complexity to ePI readiness.

How to Get It Right

While these challenges are significant, they can be addressed with the right approach:

1. Regulatory expertise and industry collaboration
   Glemser has decades of experience supporting the creation of XML-based labeling content. We actively collaborate with regulatory agencies and our clients to stay ahead of changes and contribute to industry-wide discussions. This helps us anticipate updates and align with evolving best practices.
2. Purpose-built technology
   Glemser offers systems developed specifically for authoring XML labeling content in any language. Our platforms are scalable, integration-ready, and support modern capabilities like AI-driven content suggestions and workflow automation, all with data integrity and compliance in mind.
3. Ongoing training and shared knowledge
   Our team of trained XML specialists stays fluent in key formats including FHIR, PharmaLedger, SPL, and Canadian Monograph. When not authoring content, they contribute to system enhancements and share their insights across our internal knowledge base to keep everyone aligned and informed.

Regional Momentum and Future Outlook

A growing number of regulatory agencies are implementing structured ePI standards. In addition to the EMA and FDA. Jordan has mandated eLabeling for all new submissions and Health Canada is formalizing its XML monograph format. Each of these efforts shows that the move to digital, structured content is not just theoretical, it’s happening in real time. Keeping up with these changes is key to global readiness.

Conclusion

The move to Electronic Product Information is a meaningful step forward for the industry, but it’s not without obstacles. Fortunately, more regulatory authorities are adopting ePI every year, and organizations across the globe are rising to the challenge.

Whether you’ve been working with ePI or are just beginning your journey, remember:

1. Stay connected with regulators and industry peers. Collaboration is essential to building momentum.
2. Equip your team with the right tools. The right systems can reduce complexity and increase efficiency.
3. Invest in knowledge. The more in-house expertise you develop, the more resilient and informed your process becomes.

Whether you’re modernizing your labeling process to meet new ePI requirements, evaluating structured content, or exploring initiatives like Project Orbis, staying ahead means acting now.

At Glemser, we help life sciences organizations prepare for what’s next. Our solutions and services are built for compliance, built for collaboration, and built for scale.

Let’s talk about how to future-proof your labeling. Contact Glemser today to get started.