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. The 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.

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-users.
  • An 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.

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.

It can be quite challenging to adopt a new technological update for human medicines and their respective APIs. If you are looking for assistance in adopting the common ePI standard for compliance in the EU, contact a Regulatory expert like Freyr.


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