ePI by PharmaLedger: electronic product information in 46 countries

The paper package leaflet fails at its one job: by the time a pack reaches a patient, the folded insert may be months behind the currently approved information — and it arrives in small print, in one language.

Industry pilots kept proving ePI could work; none produced shared infrastructure every manufacturer, regulator, and patient could use. Each company building its own portal would fragment the answer patients need to trust.

The 2020 EU IMI PharmaLedger project — Novartis-led, €22.1M in EU + EFPIA funding, bringing together 12 global pharmaceutical companies and 18 public and private entities — was chartered to solve exactly this class of problem. Implementing it meant re-engineering legacy labelling processes across multiple companies at once.

The consortium became a Zurich-based nonprofit association operating the Product Trust Platform: one verified product record, resolvable from the GS1 Digital Link DataMatrix already printed on packs.

After proof-of-concepts through 2022 — independently assessed at Technology Readiness Level 7, with more than 300 industry users and patient-representative focus groups involved in validation — the first version launched to member companies on 4 April 2023, entering production piloting across Asian and European markets before scaling out.

AstraLabel manages the ePI lifecycle from regulated document to structured, accessible electronic product information; a scan resolves through GS1-conformant infrastructure to the current approved leaflet for that exact product. Analytics are aggregate-only and anonymized at collection — zero personal data collected from patients.

The implementation journey is documented publicly as ISPE Pharma 4.0 Baseline Case Study No. 237 (first presented at ISPE DACH Pharma 4.0, Lausanne).