EU Trials Portal for Multilingual Electronic Product Information

Heads of Medicines Agencies

The Heads of Medicines Agencies (HMA) in Europe has launched a trial to publish electronic product information (ePI) for human medicines across the European Union on a public Product Lifecycle Management Portal.

The HMA, which is made up of the heads of national authorities responsible for human and veterinary medicines in each country of the European Economic Area, has launched the trial together with the European Medicines Agency (EMA) and the European Commission (EC).

The trial will assess the feasibility of transitioning key regulatory documents, evaluated both nationally and at a European level, to an online electronic portal. The documents include the Summary of Product Characteristics (SmPC), product labeling, and the Package Leaflet (PL), which will be publicly available in the official languages of the relevant member states.

The pilot spans 25 medicines evaluated by the EMA or by national authorities in Denmark, the Netherlands, Spain and Sweden, and will conclude in July 2024. It includes participation from well-known pharmaceutical companies, such as Sanofi and Novartis, and aims to guide best practices on extending ePIs across the EU.

Drive for e-Health

While the Product Lifecycle Management Portal itself is currently only available in English, the EU plans to extend access in all EU languages, and already allows ePI data to be accessed through an API.

This follows a similar initiative by the EMA and EC to centralize regulatory submissions through an online platform, the Clinical Trials Information System (CTIS), as part of the European Union Clinical Trials Regulation, which came into effect in January 2022 and also has a searchable public website.

As part of the EU ePI Common Standard initiative, the EU hinted at enabling “automatic update notifications, access to supportive videos or audio content, and online adverse-reaction reporting tools” for future developments, although it has not yet provided details on when or how this will be implemented.