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Breaking Ground: EMA Unveils Inaugural Release of Electronic Product Information (ePI)

Excellent news have been shared by the European Medicines Agency (EMA) on November 8th! “The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU),” said the EMA announcement.

This first step in achieving a critical mass of publicly available ePIs for downstream consumption, resulting from the ongoing ePI pilot project at EMA and in collaboration with the National Competent Authorities (NCAs) of Spain, Sweden, Denmark, and The Netherlands. Additional ePIs are scheduled for publication in the coming months, signifying an important milestone for the NCA network and consequently the Gravitate Health project. The Spanish Agency for Medicines and Medical Devices (AEMPS), the Dutch Medicines Evaluation Board (MEB) and the participating NCAs within Gravitate Health actively contribute to this pilot project.

The announcement mentions that a one-year pilot initiative, led by HMA, EMA, and the EC, is underway to explore the development and testing of ePIs in authentic regulatory procedures. This initiative aims to facilitate the transition to an electronic system for medicines evaluated both at national and European levels. Notably, the ePI initiative is a pivotal action aligned with the Pharmaceutical Strategy for Europe and is backed by the EU funding programme EU4Health.

The published ePIs are for medicines evaluated by EMA or by national authorities in Denmark, the Netherlands, Spain and Sweden. Companies participating in the pilot create and submit the ePI as part of their regulatory application. The pilot, which involves 25 medicines, will conclude in July 2024, and the outcomes will inform how to integrate the ePIs into common practice and expand their use across the EU,” according to the EMA announcement.

Gravitate Health has been working within a very dynamic landscape at a time when there is fast development of an interest in ePI globally ―to which the work of Gravitate Health has already made some important contributions (among these are the joint statement with EMA and the implementation guide (IG) for ePI). In the coming years, we will take tangible steps towards accessible and understandable digital health information about medicines for patients.

“These ePIs—the official announcement explains—were created following the EU ePI Common Standard adopted by the ‘European medicines regulatory network’ to provide a consistent structure throughout all Member States and ensure the information works across different e-health platforms. This should facilitate the use of ‘product information’ to meet individual needs and access requirements. Future developments could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction reporting tools”.

Read the full article on EMA’s website.

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