EMA: Implementation of Electronic Product Information
The EMA has published a pilot report on the creation and testing of electronic product information (ePI) in regulatory procedures. The findings suggest that the EU regulatory system is ready for ePI and can begin phased implementation, though further development is needed, including additional features and IT system integration.
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
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
