This development will continue in 2025, after which a phased approach to implementation will begin with voluntary adoption for centrally authorised products, expanding to nationally authorised products based on readiness and resources.

ePI enables patients and healthcare professionals to access up-to-date medicine information digitally. The report assessed indicators like ePI creation time, success rate, IT tool usability, and guidance materials, offering recommendations for improved support, guidance, and integration into current regulatory processes with minimal disruption.

The ePI project, led by EMA and HMA, is supported by EU4Health and involves Denmark, the Netherlands, Spain, and Sweden. It resulted in 23 ePIs for centrally and nationally authorised medicines, following the EU ePI Common Standard for harmonisation across Member States and e-health platforms. ePIs are available on the Product Lifecycle Management (PLM) Portal and through a public application programming interface (API).

Source:

EMA: News