The EMA is excited to announce a milestone achievement in collaboration with the Heads of Medicines Agencies (HMA), the European Commission (EC), and EMA. For the first time, electronic product information (ePI) for selected human medicines has been harmonized across the European Union (EU). This marks a significant step in enhancing accessibility and updating capabilities for product information.

The product information for a medicine, encompassing its summary of product characteristics, labeling, and package leaflet, is crucial in explaining how the medicine should be prescribed and used. Traditionally available as PDF documents on the websites of EU regulators, with a printed package leaflet included in the medicine’s box, this information can now be shared electronically through digital platforms. This transition holds promise for making crucial details readily available and constantly updated for end users, including healthcare professionals and patients.

A one-year pilot initiative, supported by the EU funding program EU4Health and conducted by HMA, EMA, and the EC, is actively exploring the creation and testing of ePIs in real regulatory procedures. The initiative aims to facilitate the transition to an electronic system for medicines evaluated at both national and European levels. The 25 medicines involved in the pilot, evaluated by EMA or national authorities in Denmark, the Netherlands, Spain, and Sweden, will be part of this transformative journey.

Companies participating in the pilot are required to create and submit ePIs as part of their regulatory applications. The pilot, set to conclude in July 2024, will yield valuable insights into the integration of ePIs into common practice and their expansion across the EU.

The published ePIs can be accessed at the Product Lifecycle Management Portal, available in English for centrally approved medicines and in the local language for nationally approved ones. Ongoing efforts are underway to enable access to ePIs in all EU languages. Additionally, ePI data is accessible through a public application programming interface, allowing developers to explore the potential of this new format within existing digital platforms.

These ePIs adhere to the EU ePI Common Standard, adopted by the European medicines regulatory network to ensure a consistent structure across all Member States. This standardization facilitates the use of product information to meet individual needs and access requirements. Exciting possibilities for future developments include automatic update notifications, access to supportive videos or audio content, and online adverse-reaction reporting tools.

Read more here.

References

  1. First electronic product information (ePI) published for selected human medicines | European Medicines Agency. (2023, November 8). https://www.ema.europa.eu/en/news/first-electronic-product-information-epi-published-selected-human-medicines

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