The Digital Revolution of Drug Labelling: FHIR and the Global Blueprint for e-Labelling

Today’s healthcare sector stands at the cusp of a digital transformation, and one of the most significant shifts is happening in how drug information is delivered. The rise of electronic labelling (e-labelling) is not only enhancing transparency and timeliness but also challenging regulatory systems worldwide to reimagine how drug data is shared and accessed. 

On April 22 during the “e-Labelling” session at The 14th Asia Partnership Conference of Pharmaceutical Associations, experts from various countries discussed the application of FHIR standards, current implementation progress, and strategic roadmaps, painting a vivid picture of the future of digital drug information.

From Paper to Digital: The Transformation Toward Personalized and Smart Drug Labelling

FHIR (Fast Healthcare Interoperability Resources), developed by HL7, is a standard designed to enable the interoperability of healthcare information. Craig Anderson emphasized in his keynote that traditional one-size-fits-all paper labels fail to address individual patient needs. With FHIR, drug labels can be tailored based on personal allergies, drug interactions, and contraindications, even enabling automated, real-time checks.

FHIR structures electronic Product Information (ePI) into four types:

1. Template only (Type 1)
   
2. Product details (Type 2)
   
3. Clinical details (Type 3)
   
4. Full structure (Type 4)

This classification enhances information organization and provides a step-by-step path for digital implementation. For example, the UK has standardized dosage syntax, while Jordan’s FDA has developed an app with accessibility features—clear signs of how digital innovation is reshaping global drug information practices.

Emerging Market Strategies in Asia: Case Studies from Thailand, Malaysia, and Taiwan

The session also highlighted practical implementations in Asia, where countries like Thailand, Malaysia, and Taiwan are developing diverse strategies to meet local demands and resource constraints.

Thailand has introduced a “paperless policy” by 2025 for drugs supplied to hospitals and clinics. Worasuda Yoongthing explained that although some citizens still lack smartphones or internet access, the goal is to gradually transition everyone toward digital systems. In 2025, Thailand launched an e-labelling pilot project focused on drugs with high abuse potential, incorporating a “one barcode for all information” and a track-and-trace system to enhance transparency and control.

In Malaysia, Maslinda Mahat from the National Pharmaceutical Regulatory Agency (NRPA) shared that the voluntary e-labelling phase (2023–2026) covers about 5–10% of products (around 542 items), including biologics, new drugs, and generics with scheduled poisons. The system involves scanning a QR code, which links to the NRPA Quest platform hosting the product information in PDF format. While most companies are technically ready, healthcare professionals demand proper training and offline access due to digital divide concerns—especially among the elderly and disabled. Thus, mobile-friendly and offline-capable solutions are essential.

Taiwan’s Food and Drug Administration (TFDA), represented by Mei-Chen Huang, has made significant progress: since 2022, over 7,300 structured package inserts have gone online. Taiwan released XML format standards in 2023 and began developing FHIR-based structures in 2024. The TFDA’s four-system approach includes Digitization, Standardization, Structured and Computerized Inserts, and Paperless operations. Features such as tree-view displays, subscription services, responsive web design, and open data APIs aim to improve usability and policy transparency.

Building a Universal Language: The Challenges of Consistency, Interoperability, and Digital Equity

In the panel discussion, representatives from NOVA EMLDA, Argentina’s ANMAT, and the EU’s EMA emphasized the core pillars of e-labelling implementation: consistency, interoperability, and digital equity.

Standardization goes beyond technical terms like terminology, dosage forms, routes of administration, and ingredient naming—it directly impacts regulatory recognition and reimbursement eligibility. When ePI aligns with existing healthcare systems, it significantly enhances its clinical utility.

However, the rapid advancement of AI technologies also brings risks: a widening information gap and technical barriers may marginalize certain populations. Ensuring patient-centric systems with graphical interfaces, multilingual support, and accessibility features is critical to make drug information equally available to all.

As international collaboration and harmonization deepen, e-labelling is not just about digital innovation—it is a global movement to ensure everyone has the right to safe, transparent, and up-to-date drug information.

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Author

Oscar Wu

讓生醫資訊更加流通與透明化。