The debate is over: regulators worldwide agree that the future of patient and healthcare professional information is digital. What remains under discussion is how to implement it — safely, inclusively, and in compliance with diverse national models.
Across continents, authorities are transitioning from policy intent to practical implementation of electronic product information (ePI) and digital leaflets (eLeaflets™). For marketing authorisation holders (MAHs), this shift requires building the capability to comply with a patchwork of evolving requirements — from PDF-based pilots to structured XML and HL7 FHIR standards — while preparing for an interoperable global future.
The myHealthbox eLeaflet™ solution was built for precisely this challenge. It supports the full range of regulatory expectations, allowing companies to maintain a single, authoritative content source that can be rendered and distributed according to each country’s requirements.
From Principle to Practice: The Digital Leap
Over the past two years, regulators have moved from debating the principle of digital information to implementing concrete frameworks for e-labelling and ePI. In Europe, the Inter-Association Taskforce (AESGP, EFPIA, Medicines for Europe) proposes a phased ePI rollout, with print-on-demand safeguards and full operationalisation within four years of new legislation. This mirrors the global momentum seen across Asia, the Americas, and the Middle East — all converging on digital access through QR codes, GS1 DataMatrix, or official portals.
For the industry, this shift means one thing: dual readiness. Companies must comply with today’s jurisdiction-specific e-labelling mandates while laying the foundation for structured, interoperable ePI tomorrow.
The myHealthbox eLeaflet™ Solution: Built for Global Compliance
The myHealthbox eLeaflet™ platform provides a validated, multilingual, secure environment for creating, managing, and distributing electronic product information worldwide.
Its architecture supports a unified “author once, publish everywhere” model, allowing structured and unstructured content (PDF, XML, HL7 FHIR) to coexist in the same system and be delivered per each market’s regulations.
Core capabilities include:
- Multi-format authoring and rendering – Generate eLeaflets™ in PDF, HTML, XML, or HL7 FHIR formats from a single source of truth.
- Barcode and serialization integration – Supports GS1 DataMatrix, QR codes, and GS1 Digital Link to connect packaging to the correct digital leaflet.
- Secure hosting and traceability – Controlled publishing, version history, and update validation built for GMP and regulatory audit.
- Regional compliance modules – Each country’s rules (format, hosting, update frequency, fallback) are managed through configurable templates.
- Structured ePI readiness – The system is natively compatible with FHIR and XML schemas, ensuring forward compatibility as markets evolve.
With myHealthbox eLeaflet™, companies can ensure their content remains compliant today — and ready for tomorrow’s structured, interoperable ePI landscape.
Global Regulatory Landscape: Country Snapshots
🇨🇦 Canada
Health Canada has introduced XML Product Monographs (XML PM) to replace static PDFs, with mandatory adoption from July 2025 for new drug submissions. The new format improves searchability, consistency, and integration with health data systems.
myHealthbox eLeaflet™ supports XML PM authoring and validation, automating schema checks and ensuring bilingual (English/French) compliance. It enables hybrid XML + PDF publishing, easing the transition period toward full XML submission.
🇸🇬 Singapore
Since April 2021, Singapore’s HSA has allowed e-labelling for prescription-only medicines, expanding through a pilot (April 2024 – July 2025) for non-prescription products via QR codes and secure URLs.
myHealthbox eLeaflet™ enables compliant, HSA-approved e-label delivery — ensuring up-to-date, login-free access to validated product information.
🇲🇾 Malaysia
Malaysia’s NPRA launched a voluntary e-labelling period (May 2023 – December 2026). It relies on QR codes linked to NPRA’s QUEST3+ system, hosting PDF leaflets for human medicines containing scheduled poisons.
myHealthbox eLeaflet™ generates the required PDF formats, manages QR-to-QUEST3+ linking, and supports a smooth migration path toward structured models as Malaysia’s framework matures.
🇮🇩 Indonesia
Indonesia’s BPOM established a national e-labelling pilot (Dec 2023 – Nov 2025) under Decree No. 317/2023, covering vaccines, injectables, prescription, and OTC medicines. Access is via 2D barcodes through the BPOM Mobile and Check BPOM apps.
myHealthbox eLeaflet™ integrates with BPOM’s system, automates leaflet uploads and updates, and ensures compliance with strict revision timelines and audit requirements.
🇯🇴 Jordan
Jordan’s Food and Drug Administration has mandated HL7 FHIR Type 2 (a+b) ePI linked to GS1 DataMatrix codes, marking one of the world’s most advanced implementations. Registrants must submit validated XML files that display as HTML.
myHealthbox eLeaflet™ fully supports Jordan’s FHIR model — generating, validating, and rendering structured ePI, with built-in mapping between pack DataMatrix codes and the official authority validator.
🇦🇺 Australia
Australia’s TGA continues to advance digital labelling initiatives, emphasizing structured, centralized access and QR-enabled product information.
myHealthbox eLeaflet™ aligns with these initiatives by supporting GS1 Digital Link integration and secure access via QR or URL, ensuring TGA-compliant data governance and accessibility.
🇧🇷 Brazil
Brazil’s 2024 law authorizing digital leaflets for medicines formally recognizes eLeaflets™ as equivalent to printed PILs, allowing manufacturers to replace paper with electronic versions under defined safeguards.
myHealthbox eLeaflet™ provides compliant bilingual leaflet publication, traceable QR-code linkage, and controlled updates — fully aligned with Brazil’s digital transition roadmap.
Why Now: Patient Safety, Supply Resilience, and Sustainability
Digital leaflets ensure patients and healthcare professionals always access the most current, regulator-approved information — improving safety, transparency, and pharmacovigilance. They also support multi-country packaging, streamline supply chains, and significantly reduce paper waste and CO₂ emissions, delivering measurable environmental benefits.
These combined safety, operational, and sustainability advantages are propelling regulators to accelerate the transition — not if, but how to implement it inclusively.
What “Good” Looks Like for the Industry
Today’s best-in-class labelling systems must:
- Centralize content but adapt to local formats (PDF, XML, FHIR, HTML).
- Link physical packaging and digital data seamlessly through QR or GS1 codes.
- Enforce version control and ensure consistent updates across jurisdictions.
- Provide inclusive access (e.g., print-on-demand) for patients without digital access.
- Prepare for structured ePI by investing in modular content and data governance.
The myHealthbox eLeaflet™ platform delivers on all five — enabling MAHs to navigate diverse regulatory requirements while preparing for an interoperable, data-driven ePI future.
Conclusion: The Future Is Structured, Digital, and Already Here
The global regulatory landscape is converging on the same destination — digital product information as the norm. Each market’s approach varies in pace and structure, but the trend is irreversible.
With myHealthbox eLeaflet™, companies can unify their labelling operations, comply with local mandates, and seamlessly transition to structured, validated ePI models.
The question is no longer “if” — it’s “how fast” you can make the shift.
For more information about eLeaflet™ technology and digital product information solutions, visit eleaflet.eu.
References
- Digital leaflets in Jordan
- Digital leaflets in Malaysia
- Digital leaflets in Indonesia
- Digital leaflets in Singapore
- Digital leaflets in Australia
- Brazil passes law that allows the use of digital leaflets for medicines
- myHealthbox adds support for Health Canada Product Monographs in XML format
- The myHealthbox eLeaflet™ solution for eIFU and eLabelling