Electronic Product Information Moves Forward in Europe

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The European Medicines Agency (EMA) announced on Dec. 16, 2024 that a report (1) has been published that details the results of a pilot program for the creation and testing of electronic product information (ePIs) in regulatory procedures. According to the report, the European Union’s regulatory system is prepared for the introduction of ePIs, and implementation of ePIs can be phased into regulatory procedures. More development in functionality, however, still needs to be done, according to EMA. This development will begin in 2025. EMA and the Heads of Medicines Agency developed the ePI project, which was also supported by the EU4Health funding program.

The pilot’s report recommends that a phased implementation approach happen after all functionalities are in place. This approach will begin with voluntary adoption for centrally authorized products. Implementation will expand to nationally authorized products depending on the readiness and resources of each European Union (EU) Member State.

Drug product information is provided with each authorized drug in the EU and includes a summary of product characteristics, labeling, and packaging leaflet. These documents, which can be found in the drug’s packaging and as a PDF on regulators’ websites, explain how the drug should be prescribed and used.

“The introduction of product information in an electronic format (ePI) compatible with digital platforms opens new possibilities for patients and healthcare professionals to access and interact with vital, up-to-date information about their medicines,” EMA states in the press release (2).

Key indicators that were evaluated during the pilot included time needed to create an ePI, the percentage of ePIs that are successfully created and published, and usefulness of IT tools and guidance materials. These indicators were factored into the recommendations regarding future work that might be needed to implement ePI into current regulatory processes. The report states that enhanced guidance to support users and an update to business processes should be performed to ensure minimal disruption during implementation.

“In order to promote ePI adoption by companies, it is recommended to consider putting a process in place for a limited time period to allow first-time ePI submission and publication outside of a regulatory procedure. Importantly, regulators participating in the pilot found that it will be necessary to link ePI submission to the electronic application form and, for centrally authorized products, to the IRIS procedure management system, which will require a significant development effort,” the report states (1).

The pilot involved EMA, the national authorities of Denmark, the Netherlands, Spain, and Sweden, and industry. Twenty-three ePIs from real regulatory procedures were published as part of the pilot, of both centrally and nationally authorized medicines. The ePIs were created following the EU ePI Common Standard, “which provides a harmonized structure throughout all Member States ensuring the information works across different e-health platforms for citizens in the EU.” These ePIs can be found on the Product Lifecycle Management Portal.

References

1. EMA; HMA. ePI Pilot Report. Experience Gained from Creation of ePI during Regulatory Procedures for EU Human Medicines. Dec. 16, 2024. https://www.ema.europa.eu/en/documents/report/electronic-product-information-epi-report-experience-gained-creation-epi-during-regulatory-procedures-eu-human-medicines_en.pdf
2. EMA. Successful Pilot Paves the Way for Implementation of ePI. Press Release. Dec. 16, 2024.