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The European Medicines Regulatory Network (EMRN) has adopted a common electronic Product Information (ePI) standard for human medicines. The common ePI standard was one of the major projects undertaken by the European Medicines Agency (EMA), the National Competent Authorities (NCA), and the European Commission (EC). The EU Network Data Board adopted the EU ePI common standard in September 2021, and the announcement was made on February 22, 2022.
The PI includes the package leaflet for the patients and the Summary of Product Characteristics (SmPC) for the healthcare workers. It offers the recommended usage and prescription information and is an integral part of every medicine marketed in the EU. In the ePI, an electronic version of the PI, details such as the SmPC, package leaflet, and labeling can be accessed on the web, e-platforms, and print.
What is the ePI Common Standard?
Generally, the respective Regulatory Authority and stakeholders (sponsors, drug manufacturers, etc.) agree on the technical features of the ePI. The latest common standard ensures harmonized electronic information on human medicines. The authorized information for a drug is updated in a semi-structured format on electronic portals. The ePI common standard is based on Fast Healthcare Interoperability Resources (FHIR), a technical standard used to describe data formats and elements. FHIR is an application programming interface for exchanging electronic health records.
The common ePI standard includes the following:
- The ePI Active Pharmaceutical Ingredient (API) specification and the associated ePI API service list
- An FHIR template based on the Quality Review of Documents (QRD) template for human medicines
As part of the EU Pharma Strategy and digital health transformation, the adoption of the ePI standard will further support interoperability, efficient Regulatory reporting, and seamless updates to real-time medicinal information across the EU. The standard integrates with master data (SPOR) and streamlines electronic submissions. ePI also supports multilingual labeling, user-friendly interface design, integration with eHealth platforms, and data analytics for regulatory compliance and pharmacovigilance.
Benefits of Adopting the ePI Common Standard
- A harmonized electronic information system for medicines within the EU
- Enhanced and timely delivery of information to help patients, healthcare professionals, and other end-usersAn accessible electronic system for users that can be checked from the comforts of their respective homes
- Information on all the medicines is updated and made available on a real-time basis
- The EMA plans to include automatic update notifications, audio and video content to support the PI, and online adverse reaction reporting systems in the future
With ePI, the EU strengthens patient safety, health literacy, transparency, and accessibility. The EMA plans to include automatic update notifications, audio and video content to support the PI, and online adverse reaction reporting systems in the future. The transformation to ePI enables seamless Regulatory lifecycle management, supports clinical trial labeling, digitalizes labeling compliance, and enables real-time tracking of medicinal information.
Implementation of the ePI Common Standard
The EMA is conducting a pilot project of the ePI for ePI in Regulatory procedures. The said project is being funded by the EU4Health Programme, which runs from 2021 to 2027.
Global manufacturers, sponsors, and Regulatory affairs professionals can leverage ePI standardization for faster digital submissions, improved clinical trial labeling, enhanced pharmacovigilance, precise labeling updates, and better compliance with EMA, NCA, and EC requirements. For strategic e-labeling solutions, digital PI lifecycle support, and regulatory intelligence on EU ePI adoption, consult Freyr Solutions.
