Electronic Product Information (ePI) is authorized, statutory information for medicines, covering patient information leaflets and the Summary of Product Characteristics for healthcare professionals. It adheres to a semi-structured format with the common EU electronic standard, optimized for electronic handling, internet dissemination, and compatibility with healthcare information systems. Despite print options, the primary aim of ePI development is to improve access to current medicine information. The benefits of ePI include enhancing public health, optimizing regulatory system efficiency, aligning with legislative frameworks, complementing paper leaflets, accommodating the EU’s multilingual environment, and interacting with ongoing digital initiatives at EU and global levels.
The Heads of Medicines Agencies (HMA), the European Commission (EC), and the European Medicines Agency (EMA) have jointly introduced electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). This initiative marks an effort to transition from traditional printed documents to a dynamic, digital system facilitating real-time updates and broader accessibility for healthcare professionals and patients.
The product information of a medicine, including its summary of product characteristics, pharmaceutical labelling, and package leaflet, accompanies every authorised medicine in the EU, providing guidance on prescription and usage. Traditionally available as PDF documents on regulatory websites, these documents are now being transformed into an electronic format, discovering new possibilities for efficient sharing, constant updates, and improved accessibility through digital platforms.
Pilot Initiative for Testing and Integration
HMA, EMA and EC launched a year-long pilot project to investigate the practical implementation of ePIs. The pilot includes medicines evaluated by the EMA or the national authorities of Denmark, the Netherlands, Spain and Sweden, involving a total of 25 medicines. Participating companies create and submit ePIs as part of their regulatory filings. The results of this initiative, expected to be completed in July 2024, will guide the integration of ePIs into general practice and their expansion across the EU.
EPIs can be accessed from the product lifecycle management portal, which provides information on centrally approved medicines in English and nationally approved medicines in a local language. Ongoing testing aims to enable access to ePIs in all EU languages. Additionally, developers can explore the possibilities of this new format through a public application programming interface (API) that drives innovation on existing digital platforms.
When creating ePIs, the uniform EU ePI standard is followed, which ensures a uniform structure in all member states. The purpose of this standard is to match information with different eHealth platforms, which facilitates customised use according to individual needs and requirements. Future developments may include features such as automatic update notifications, access to supporting multimedia content and web-based adverse reporting tools.
The Medicines Evaluation Board (MEB), in collaboration with four other medicines agencies, has played a significant role in publishing the first ePIs. The MEB assesses and publishes ePIs created during the pilot project, which includes national regulatory procedures conducted by medicines agencies in Spain, Sweden, and Denmark, and centrally coordinated procedures by EMA.
The implementation of ePIs, within the European Union, marks a link between authorities and healthcare envisioning a future where medical information is personalised for patients and professionals. The ongoing pilot program and collaborative initiatives highlight a dedication to improving healthcare information systems focusing on effectiveness, ease of access and better public health results. This achievement signals a user customised approach to medical information with joint efforts aiming to smoothly integrate precise and current information into forthcoming digital healthcare platforms.
DDReg offers expert regulatory consulting and pharmacovigilance support to pharma companies across the globe. As part of its regulatory affairs portfolio, DDReg has supported its customers with product information services including authoring and review of SPC and PIL in accordance with country regulations. Read the previous blog on what additional measures EMA is taking to address medicine shortages in Europe.