EU adopts electronic product information standard for medicines

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in the European Union (EU).

According to the European Medicines Agency (EMA), the standard will enable the wider dissemination of unbiased, up-to-date information on all medicines available to patients in the EU through an expanding range of electronic channels.

The product information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. The EU ePI Common Standard will support the provision of harmonised electronic information on medicines within the EU and, according to the EMA, is a step towards improved delivery of information for patients, consumers and healthcare professionals.

The ePI can be updated immediately with new information. The structured nature of ePI will also offer new opportunities to personalise the product information to individual needs and to make it more easily accessible to users with diverse abilities, said EMA. Future developments of the ePI could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction reporting tools.

The Common Standard was one of the key deliverables of an ePI project run by EMA, national competent authorities (NCAs) and the European Commission (EC) in 2021. A follow-on pilot project supported by the EU’s funding programme EU4Health will now focus on developing tools and guidance to pilot the use of ePI prior to implementation.

EMA stated that it will publish regular progress updates and will share the results with patients, healthcare professionals, academia and the pharmaceutical industry.

The adoption of the Common Standard is in line with the ePI key principles which were established following stakeholder consultations and guide the development of the ePI in the EU. The EU ePI Common Standard is based on Fast Healthcare Interoperability Resources (FHIR), an international technical standard describing data formats and elements and an application programming interface for exchanging electronic health records. FHIR also supports the exchange of information about medicinal products, substances and related referential data in the European medicines regulatory network.