ePI IG for APAC markets
0.1.0 - ci-build

ePI IG for APAC markets, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/scc88/aseanepi/ and changes regularly. See the Directory of published versions

Appendix 2

Adopting the ASEAN FHIR ePI standard does not mean abandoning the familiar, local Patient Information Leaflet (PIL) formats used in your jurisdiction.

By leveraging the FHIR ePI standard, a single structured Medicinal Product Information data file can be automatically transformed into beautiful, interactive, and locally-compliant digital leaflets.

Core Business Benefits

  1. Write Once, Publish Anywhere: Manage your core product data centrally. The presentation layer dynamically adapts the data to meet specific regional regulatory requirements (e.g., varying section headings).
  2. Enhanced Patient Safety: Move beyond static PDFs. FHIR enables interactive "Clinical Details" featuring automated dosage tables, clear warning summaries, and easily accessible side-effect profiles.
  3. Cost Efficiency: Accelerate the transition from costly printed paper inserts to dynamic, responsive digital platforms that are easier to update and maintain.

Below are interactive mockups demonstrating how the ePI standard seamlessly adapts to five distinct regional formats within the ASEAN region while sharing the exact same underlying technology.

Click the links below to view the interactive mockups in your browser.

Indonesia (BPOM Format)

Demonstrates full localization into Bahasa Indonesia, featuring the comprehensive 25-section (A–Y) Informasi Produk untuk Pasien structure. 👉 View Interactive Mockup

Malaysia (RiMUP)

Showcases the 12-section consumer medication information leaflet format in Bahasa Malaysia. 👉 View Interactive Mockup

Thailand PIL

Fully localized in Thai (ā¸ ā¸˛ā¸Šā¸˛āš„ā¸—ā¸ĸ) implementing the 7-section national format. 👉 View Interactive Mockup

Philippines PIL

Features the standard 21-point patient information leaflet layout presented entirely in layperson English. 👉 View Interactive Mockup

ASEAN Core Template

A unified baseline structure supporting 19 sections for cross-border harmonization. 👉 View Interactive Mockup

Note for Implementers: All mockups above are "ePI Type 3" showcases. They feature interactive tabs separating regulatory document metadata, the localized leaflet composition, and tabular clinical details.