EMA preps for EU common standard on electronic product information

Regulatory NewsRegulatory News | 08 June 2021 |  By 

The European Medicines Agency (EMA) this week launched a stakeholder consultation on a draft EU common standard for electronic product information (ePI) for human medicines.
The common standard would provide a semi-structured template for ePI incorporating the authorized, statutory product information for medicines, including the summary of product characteristics (SmPC), labeling and package leaflet. EMA says that ePI will be better suited “for electronic handling and allows dissemination via the web, e-platforms and print.”
Last year, EMA, the European Commission and Heads of Medicines Agencies (HMA) released a set of principles outlining a harmonized approach to ePI. The release of the principles followed a 2017 report from the Commission which identified ePI as a way to improve how EU citizens access information about medicines and an EMA workshop on the topic in 2018. (RELATED: EMA preps for better electronic delivery of package leaflets, product information, Regulatory Focus 21 November 2018; EU agencies outline approach to electronic product information, Regulatory Focus 29 January 2020).
In addition to the stakeholder consultation, EMA will host a series of virtual workshops “designed to inform on the standard and explore its future use.” The agency also says that the workshops will ensure that the eventual standard meets the needs of users and will facilitate access, viewing and dissemination of product information in an electronic format.
The workshops include an informational event on 5 July for stakeholders and partners, followed by three exploratory workshops on 6, 7 and 8 July intended for technical specialists who will carry out “hands-on development tasks” related to the ePI API.
Consultation documents include an ePI application program interface (API) and ePI API service list, a Fast Healthcare Interoperability Resources (FIHR) XML template and an ePI sample message in various programming languages.


© 2022 Regulatory Affairs Professionals Society.

Tags: EMA, ePI, EU, labeling

Discover more of what matters to you

No taxonomy