The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have recently concluded a successful pilot project on electronic product information (ePI), marking a significant advancement in the digital transformation of medicinal product information within the European Union.
Traditionally, product information, including the summary of product characteristics (SmPC), labeling, and patient information leaflets (PIL), has been provided in paper form and as PDF documents on regulatory websites. The pilot for ePI is regarded as an add-on to the product information in its current form and introduces a dynamic, electronic format compatible with digital platforms that enhances accessibility and ensures patients and healthcare professionals have immediate access to the most current information.
The pilot was supported by the EU4Health program and involved collaboration between the EMA, national authorities from Denmark, the Netherlands, Spain, and Sweden, and industry stakeholders. Over the course of the project, 23 ePIs were successfully created and published, encompassing both centrally and nationally authorized medicines. These ePIs adhered to the EU ePI Common Standard, ensuring consistency and interoperability across various e-health platforms throughout EU Member States.
Key performance indicators assessed during the pilot included the time required to create ePI, the success rate of ePI creation and publication, and the usability of IT tools and guidance materials. The findings indicate that the EU regulatory system is prepared to commence a phased implementation of ePI within regulatory procedures. Initial efforts in 2025 will focus on developing additional functionalities and integrating ePI with existing IT systems. Subsequently, a voluntary adoption phase for centrally authorized products will begin. This will gradually extend to nationally authorized products as Member States become ready and resources permit.
As the pharmaceutical industry embraces digital transformation, electronic product information is emerging as a pivotal innovation in drug development, regulatory compliance, and patient engagement. The transition from traditional paper-based documentation to digital formats is set to revolutionize how drug information is created, disseminated, and utilized across the healthcare ecosystem. For professionals in drug development the ePI presents tangible benefits that enhance efficiency, accuracy, and accessibility.
Regulatory affairs teams are continuously challenged by evolving guidelines, submission requirements, and the need for real-time updates on drug safety and efficacy. ePI streamlines regulatory compliance by facilitating instant updates and harmonization across jurisdictions, reducing administrative burdens, and ensuring that product information remains accurate and aligned with the latest scientific findings. Additionally, ePI supports standardized formatting, enhancing transparency and consistency in documentation.
Safety monitoring and regulatory compliance are critical aspects of pharmaceutical management. ePI enables real-time updates, ensuring that healthcare professionals are aware of any newly identified risks, adverse reactions, or dosage adjustments without delays. By streamlining pharmacovigilance processes, ePI supports proactive risk management and ensures patients receive the safest possible treatments.
As patient empowerment becomes a central focus in healthcare innovation, ePI plays a crucial role in ensuring direct patient access to comprehensible, multilingual, and interactive drug information. By incorporating user-friendly digital elements such as adaptive text sizes, video tutorials, and QR-code access, ePI enhances patient adherence, informed decision-making, and treatment outcomes. This shift aligns with industry efforts to develop patient-centric drug formulations and personalized therapeutic approaches.
Transitioning from paper-based documentation to digital ePI aligns with sustainability goals by reducing the environmental footprint associated with printing, transportation, and disposal of outdated leaflets. Additionally, the ability to digitally update and distribute product information lowers production costs and eliminates inefficiencies linked to physical documentation revisions and reinforces long-term sustainability in pharmaceutical operations.
For Sponsors, the implementation of ePI will necessitate adaptations in regulatory submission processes and IT infrastructure to comply with the new standards. Engaging with the phased implementation plan and participating in the development of ePI functionalities will be crucial for a smooth transition.
Companies are encouraged to familiarize themselves with the EU ePI Common Standard and assess their readiness to integrate ePI into their product information workflows.
As the EMA and HMA proceed with the phased implementation, staying informed about updates and participating in stakeholder consultations will be essential for sponsors to effectively navigate this transition.
The move towards ePI not only enhances information accessibility for end-users but also represents an opportunity for companies to streamline their regulatory processes and contribute to a more efficient healthcare information ecosystem.
ProPharma is well-positioned to support pharmaceutical companies in navigating this transition to ePI. With our expertise in regulatory affairs and our comprehensive understanding of EU requirements, we can assist clients in adapting their regulatory submission processes, implementing IT systems aligned with the EU ePI Common Standard, and ensuring compliance throughout the phased implementation. Our team is committed to partnering with you to optimize your ePI strategies and streamline your transition into this innovative digital framework.