The European Medicines Agency (EMA) and national regulatory agencies are piloting electronic product information (ePI) generation for regulatory procedures.
EMA defines ePI as authorized, statutory product information for medicines, including the summary of product characteristics, package leaflet and labeling, adapted for handling in an electronic format and for dissemination online and in print. The agency sees switching to ePI as a way to improve accessibility, searchability and multilingual capabilities and to keep information up to date.
EMA has partnered with regulatory agencies in Denmark, Netherlands, Spain and Sweden. Starting in July, the partners will spend a year using an ePI authoring tool in the Product Lifecycle Management (PLM) Portal.
EMA created the PLM Portal to manage electronic application forms, ePI and authorized product data in the EU. In the pilot project, EMA and its collaborators will use the authoring tool in the portal to generate ePI for regulatory procedures in real-time. Once regulators approve the ePI, they will make it available publicly.
The pilot will cover centralized and national procedures. As the pilot progresses, EMA will share updates on its work on ePI, which uses a semi-structured format based on a common electronic standard for product information, as part of its quarterly public system “demo events.”
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