igital transformation in regulatory systems is neither a single project nor a final destination. It is an ongoing process that reshapes how information is generated, governed, and used across health systems. Within this evolution, electronic product information (ePI) has emerged as a key enabler to modernize regulatory information governance, strengthen public trust, and improve decision-making throughout the product lifecycle. Now this transformation applies to the pharmaceutical package leaflet.

For decades, the paper package leaflet has been the primary mechanism for communicating approved product information to patients and healthcare professionals. While essential, this model presents structural limitations: slow updates, limited accessibility, challenges for comprehension, and an increasing disconnect from the digital environments where clinical, regulatory, and policy decisions are now made. The transition toward ePI reflects not only technological change but also a deeper transformation in how regulatory information is understood as a public good.

Regulatory Information as a Public Good

Regulatory information underpins transparency, patient safety, operational efficiency, and institutional trust. When information is accessible, reliable, and up to date, it supports evidence-based decisions, reduces duplication, improves regulatory performance, and strengthens the relationship between authorities, industry, healthcare professionals, and patients. Moving from paper to digital formats therefore represents a qualitative leap in information governance. It is not simply about digitizing existing documents; it is also about rethinking how regulatory information is structured, maintained, and reused within increasingly interconnected health ecosystems.

What ePI Is and Is NOT

Electronic product information can be defined as the authorized and maintained digital version of approved product information, presented in electronic formats that allow controlled updates, traceability, and, where appropriate, interoperability with other systems. Importantly, ePI is not synonymous with static PDF leaflets hosted online. Its long-term value lies in the use of structured and interoperable formats, aligned with international standards, that enable integration across regulatory platforms, clinical systems, and patient-facing digital tools. Equally important, ePI does not automatically replace the paper package leaflet. Its implementation requires balance between content, format, access, and governance, as well as inclusive transition models that ensure no patient is left behind.

Strategic Value of ePI

From a strategic perspective, ePI delivers value across multiple dimensions:

• From a patient safety standpoint, ePI enables access to accurate and current information, reduces reliance on outdated content, and supports patient-centered digital solutions using widely adopted access technologies such as QR codes, DataMatrix codes, secure URLs, and other machine-readable identifiers, as well as accessible digital platforms tailored to different user needs.
• In terms of transparency and trust, ePI reinforces perceptions of modern, accountable regulatory systems aligned with international best practices. Public availability and traceability of information strengthen institutional credibility and dialogue with society.
• ePI also contributes to operational efficiency, reducing manual processes, minimizing rework, supporting supply chain management, and improving traceability across the product lifecycle.
• Finally, from a sustainability perspective, the progressive reduction of paper use and process optimization offer both environmental and operational benefits.

Alignment with Global Digital Health Strategies

The evolution of ePI is closely aligned with global digital health agendas that promote patient-centered systems, interoperability, and the responsible use of digital technologies to improve health outcomes. International strategies increasingly recognize that trusted digital information is foundational to effective regulation, pharmacovigilance, and emergency preparedness. Growing global interest in ePI aligns with the World Health Organization’s (WHO) Global Strategy on Digital Health 2020–2025, which highlights the transformative potential of digital technologies to accelerate human progress, bridge the digital divide, and foster knowledge development.

In the Americas, regional digital health action plans emphasize strengthening health information systems and improving access to reliable regulatory information, positioning ePI as a key enabler for decision-making and system resilience. For example, the Pan American Health Organization (PAHO) has adapted the WHO strategy into regional action: In 2021, PAHO published its 8 Principles for the Digital Transformation of Public Health, advocating for inclusive, equitable, sustainable digital health systems.

International Landscape: Lessons from Different Regions

Globally, ePI implementation has progressed in a heterogeneous and pragmatic manner, with most jurisdictions adopting gradual or hybrid models where paper and digital formats coexist during transition periods.

In the US, full ePI implementation has not yet been adopted. The FDA continues to rely on printed information for dispensing while using Structured Product Labeling as a standard for electronic submission and exchange of labeling content. This distinction highlights the difference between electronic data exchange and user-facing ePI deployment.

In Europe, the adoption of a common ePI standard and the development of pilots based on structured formats illustrate coordinated efforts to enable electronic product information while preserving inclusive access. National initiatives, such as Spain’s experience with hospital-use medicines, demonstrate how controlled transitions can reduce reliance on paper while maintaining patient safeguards.

In the Asia-Pacific region, several jurisdictions have enabled regulatory flexibility for electronic access to product information through phased approaches. Australia has long allowed differentiated requirements for paper leaflets depending on product type and setting of use, while Japan has implemented regulatory changes to progressively reduce reliance on paper and promote electronic access to approved product information.

Singapore represents an additional relevant example. The Health Sciences Authority (HSA) has issued regulatory guidance on electronic labeling, allowing product information to be made available in digital formats accessed through QR codes, DataMatrix, or secure links, with or without coexistence of printed leaflets. The approach follows a phased implementation model, beginning with prescription medicines and emphasizing content accuracy, accessibility, and governance, reinforcing the value of gradual adoption supported by clear regulatory expectations.

Jordan offers a notable example of structured ePI implementation, with its regulatory authority advancing electronic product information using international interoperability standards and accessibility features, supported by a staged regulatory roadmap.

In Latin America and the Caribbean, several countries have advanced through hybrid models, incorporating digital access mechanisms such as QR codes and official repositories while maintaining paper leaflets during the transition. A particularly relevant case is Brazil, where ANVISA adopted RDC 885/2024, establishing regulatory requirements for digital package inserts accessed through QR codes and official information environments. The Brazilian experience illustrates how a clear regulatory framework can support scalable and inclusive adoption in large and complex systems.

Taken together, these examples confirm that there is no single ePI model but there are varied attempts at implementing ePI in several regions. Successful approaches share common principles: gradual implementation, coexistence of formats during transition, clear content governance, and a patient-centered focus.

The Latam ePI Playbook: From Experience to Guidance

Against this backdrop, the LatAm Playbook for Electronic Product Information Implementation, launched in early 2026, represents a significant regional milestone. Developed by FIFARMA with the collaboration of a diverse group of experts, including members of the EFPIA LatAm Regulatory Network, the Playbook reflects a genuinely collaborative and multisectoral effort.

The Playbook is not a technical manual or a regulatory guideline. Its objective is to provide a comprehensive view of the current and future landscape for ePI in Latin America and the Caribbean, incorporating perspectives from industry, NRAs, patients, HCPs, and other stakeholders. It is a practical orientation tool designed to support regulators, industry, and other stakeholders in understanding, planning, and progressively implementing ePI in line with national contexts and priorities in a structured, stepwise framework to support collaboration, regulatory dialogue, and progressive convergence over time.

Stepwise Implementation Approach

A core principle of the Playbook is the stepwise approach, understood as a phased and progressive implementation model. This approach acknowledges that countries start from different levels of regulatory maturity, digital infrastructure, and institutional capacity. Rather than a sudden transition, the stepwise approach allows systems to begin with feasible solutions, such as hybrid models combining paper leaflets with basic digital access, and gradually evolve toward structured, interoperable, reusable electronic information.

This model reduces regulatory and operational risk, facilitates user acceptance, and builds trust in digital transformation processes. It promotes cycles of piloting, learning, and adjustment, aligned with public health priorities and local realities. In this way, ePI is positioned not as a technological mandate but as a natural evolution of regulatory information governance.

While the Playbook was developed for Latin America and the Caribbean, its underlying principles are broadly applicable. The region’s regulatory diversity, uneven digital maturity, and strong momentum for modernization make LatAm a particularly relevant use case for pragmatic, scalable ePI implementation. The lessons captured in the Playbook may therefore inform discussions in other regions facing similar challenges.

Looking Ahead

The evolution of ePI offers a tangible opportunity to strengthen regulatory systems, improve patient experience, and advance more resilient and transparent health ecosystems. The LatAm Playbook represents a concrete step toward translating global concepts into actionable guidance, grounded in real-world experience. Ultimately, the transition from paper to digital information is not about replacing one format with another. It is about building trusted, inclusive, future-ready systems in which regulatory information truly functions as a public good.