P309: ePI for Prescription Medicines: A Review of Challenges and Opportunities Across International Markets
Poster Presenter
Carmen Lin
Global Regulatory Affairs Content Strategist Specialist
Roche Canada
Objectives
To analyze the current landscape of electronic product information (ePI) across the globe and identify the key challenges and opportunities in its implementation. To gain an understanding of the regulatory guidelines and policies on ePI across international markets and how they compare and contrast.
Method
A scoping review of publicly available sources examined the adoption of e-labeling. Keyword searches using terms such as “electronic product information,” “e-labeling,” “regulatory guidance,” and “digital health,” provided results on official websites of national regulatory authorities.
Results
The findings are expected to highlight the key challenges of ePI initiatives, such as adopting new technology in resource-limited settings and differences in regulatory guidelines. Conversely, key opportunities include increased patient engagement, improved alignment of drug information across regions, and supporting environmental sustainability through the reduction of printed materials.
Conclusion
The report highlights the importance of collaborative efforts to support the global adoption of ePI, ultimately aiming to improve patient safety, decision making at the healthcare provider level, and streamline regulatory processes.
