eLabeling and Healthcare Interoperability Accelerate Health Innovation for Patients

Insights: Global Labeling Conference

eLabeling and Healthcare Interoperability Accelerate Health Innovation for Patients

Rie Matsui
Pfizer R&D Japan

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veryone agrees that product information for pharmaceuticals should be as accessible as possible and in a format that allows all consumers, whether they are healthcare professionals or patients, to easily digest and understand it. Several eLabeling initiatives have been implemented around the world since 2021. But now there is a new game in town.

In Japan, the Pharmaceuticals and Medical Devices Act was amended to replace paper labeling in 2019. The enforcement of the amendment began on August 1, 2021, and came into full effect on July 31, 2023. In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) issued its Guideline on eLabelling for Pharmaceutical Products in April 2023. It is voluntary for companies to implement eLabeling where physical labels need not be distributed with the pack.

In this phase, eLabeling is most often published on the regulatory agency and/or marketing authorization holder websites as PDFs that are digitally connected to QR or Data Matrix codes on the physical package. Paper labeling can be voluntarily removed from some products (such as hospital products) as a part of this initiative, which is still ongoing.

However, structured content labeling based on Fast Healthcare Interoperability Resources (FHIR) developed by Health Level Seven International (HL7) is advancing these discussions in a different direction.

A new common international standard for structured eLabeling, FHIR has made massive inroads in solving longstanding healthcare interoperability issues. For example, hospitals, clinics, and lab systems often use different or proprietary data formats, which makes it difficult for these systems to talk to each other. FHIR solves this issue by providing a standardized, web-based format for representing and exchanging healthcare data across any compliant system, making disparate healthcare systems more compatible with the internet and with each other in the same way that online banking or shopping allows consumers to access different vendors, even across international boundaries, in the same online session.

An international coalition of experts collaborated to develop a FHIR standard for labeling called Electronic Medicinal Product Information (ePI). This coalition includes Gravitate Health (a public-private partnership cofunded by the European Commission and the European Federation of Pharmaceutical Industries and Associations [EFPIA]), HL7’s Vulcan Accelerator, the European Medicines Agency (EMA), and the Uppsala Monitoring Centre (UMC)/Global IDMP Working Group (GIDWG). The FHIR ePI standard is described in the Implementation Guide (IG). The IG provides guidance on how to build ePIs in compliance with rules common to all jurisdictions (e.g., technical style guide, XML structure, core FHIR validation rules, etc.). Complementary regional or country-specific IGs are being developed to provide guidance and compliance rules unique to each jurisdiction (e.g., local terminology and identifiers, local label template section headings, and local business validation rules). The global and the country-specific IGs are maintained in sync through transparent sharing of lessons learned and open collaboration to develop improvements under HL7.

Through FHIR, ePI structures the contents of a label and then breaks the label content into standardized components that can be reconfigured in different orders to suit different use cases. Common business use cases for FHIR eLabeling currently include personalized labels and automated generation of package artwork; plans for future implementation include developing an end-to-end regulatory workflow using FHIR that would allow real-time exchange between the reviewers and the applicant in a common format.

The EMA representative at DIA’s 2025 Global Labeling Conference (see below) shared the agency’s vision to (1) make up-to-date and accessible, regulator-authorized ePI available for EU Centrally Authorised Products (CAP) and Nationally Authorised Products (NAP) in all EU languages; and (2) facilitate access by patients and healthcare professionals to support safe and effective use of medicines and management of product shortages.

Regarding EMA’s use of FHIR as the foundation for the EU ePI Common Standard for health data resources, EMA developed the Product Lifecycle Management portal for ePI and completed the ePI pilot in 2024 and continues to work toward making label content more accessible to all patients to support more informed decision-making by patients and healthcare professionals and improve patient safety overall.

The Jordan Food & Drug Administration (FDA) has made the new FHIR ePI format mandatory by the end of 2025 and has already developed a national health app that would publish and present these drug labels to patients. Enhancements incorporated in this app give patients the opportunity to read the label in either light mode or dark mode; to activate text to audio (speech) playback by clicking the “play” button; or to receive the label content as a sign language video. Patients who cannot manipulate these buttons or this screen by hand can activate the facial tracking feature, which tracks and uses the reader’s facial expressions to manipulate and move between screens without using their hands. Another enhancement presents the version of the label aligned with a specific batch formulation to ensure that patients are reading the most recent and relevant version.

Patient-Centric Labeling for Shared Decision-Making

The topic of patient-centricity is not new. But it remains an important component of eLabeling, patient labeling, package designs, and related discussions. Patients’ health literacy is a critical component in building patient-centric labeling, and patient-centric labeling is essential for effective shared decision-making.

eLabeling will also require reconsideration of readiness for audits and inspections; for example, the need to establish new processes to ensure that the correct version of the eLabel is being made available to end users via scanning a machine-readable code. Artificial intelligence can be useful in current processes, but full adoption will require strategic considerations and new skills (such as prompt engineering) to realize its full benefits in the labeling ecosystem. Standardizing the eLabeling framework and global regulatory harmonization are also necessary for success.

FHIR promises to bring in a new era of innovation to labeling: FHIR eLabeling can consider and accommodate regional and local healthcare systems, provide interoperability between these systems, and present opportunities to use structured labeling content in real-life settings. The experience shared by Jordan’s FDA illustrates the importance of international collaboration and the innovative potential of emerging markets.

Labeling is not just a piece of paper anymore.

Patient-centricity and health literacy, interoperable resources, and globalization—established and essential keywords in modern clinical research and drug development—were the three key topics discussed throughout DIA’s 2025 Global Labeling Conference as effective approaches to developing and managing clear, accurate, compliant labeling information for prescription drugs, biologics, and medical devices. As part of this focus on patient-centricity, interoperability, and globalization, eLabeling (electronic labeling), patient-centric labeling, safety labeling, end-to-end labeling processes, professional development for labeling, human factor testing, artificial intelligence (AI), cell and gene therapy labeling, and other important subtopics were introduced throughout these discussions.

The author thanks Craig Anderson (Pfizer), Juan Garcia (EMA), and Rabi Mohd (Jordan FDA), whose presentations at this event formed the basis for this article.

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