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Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.
The European Medicines Agency (EMA) announced on Nov. 8, 2023 that the Heads of Medicines Agencies (HMA), the European Commission, and EMA have published electronic product information (ePI) for selected medicines that have been harmonized across the European Union. The published ePIs are part of a one-year pilot program, under the Pharmaceutical Strategy for Europe, for the transition of information to an electronic system. Companies participating in the program create and submit the ePI as part of a regulatory application. The published ePIs include medicines that were evaluated by EMA or national authorities in Denmark, the Netherlands, Spain, and Sweden. The pilot program includes 25 medicines and will conclude in July 2024.
A Product Lifecycle Management Portal is available to view the ePIs in English for centrally approved drugs and in the local language of nationally approved medicines. ePI data can also be accessed via a public application programming interface.
According to EMA, medicine product information is provided for each authorized drug in the EU and includes a summary of characteristics, labeling, and a package leaflet. The information can also be found on EU regulator websites. “Digital platforms open new possibilities to share this information electronically, keep it constantly updated and make it more accessible to end users such as healthcare professionals and patients,” EMA stated in a press release.
“These ePIs 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,” the agency stated in the release.