A major step has been reached in the digital transformation of medicines information across the EU. The European Medicines Agency (EMA) has published its updated roadmap for the implementation of electronic Product Information (ePI).
The initiative will start with a pilot phase focused on vaccines, followed by expansion to oncology products and, ultimately, all centrally authorized products (CAPs). This phased approach enables continuous monitoring, learning, and refinement throughout the process.
Key features under development include:
- Development and adaptation of business processes for CAPs and NAPs
- Guidance development
- Stabilization and performance optimization
- User Acceptance Testing (UAT)
- Additional Product Lifecycle Management (PLM) portal functionalities
- Integration with IRIS eSubmission
At Asphalion, we are ready to support you throughout every stage of this transition. Contact us at: [email protected]
Explore the full roadmap here: https://bit.ly/4tUCplH
