Why the Swedish Medical Products Agency selected Fonto
14 Oct 2022
5 mins
Lakemedelsverket, the Swedish Medical Product Agency (MPA), recently turned its back on Microsoft Word and chose Fonto's XML editor for a national pilot study for pharmaceutical companies creating Electronic Product Information (ePI).
In case you're not familiar with ePI, it relates to authorized, statutory product information for medicines (and includes a Summary of Product Characteristics, Package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and print.
Fonto Editor will be configured for the XML-based FHIR standard that will be used for this pilot. The FHIR® (Fast Healthcare Interoperability Resources) standard defines how healthcare information can be exchanged between different computer systems, regardless of how it is stored in those systems.
The information will be readable for machines as well as for the human eye. This will enhance availability for use within e-health systems used by the health care, pharmacies and patients.
Setting up this structured content authoring solution will replace the current stream of MS Word documents that are shared between the medical products agency and pharmaceutical companies. This is fully in line with the importance of content in drug approval, we mentioned earlier.
"It was important to have a browser-based XML tool with possibilities for WYSIWYG editing properties," Kim Sherwood, Senior Expert Product Information Assessor, Lakemedelsverket. "Furthermore we saw an advantage in experience and knowledge from structuring of product information for medicinal products."
To enable this digital format for product information for medicinal products, a national project has been started. In the next two years, the Swedish MPA will focus on granularity and coded information elements, including electronic structure of the product information template in headings and sections.
European Medicines Agency
In parallel, EMA (The European Medicines Agency) is running a project which in the next two years will develop a tool and portal for semi-structured (headings and sections) product information for both centralized and nationally approved medicinal products. During the coming years, the Swedish MPA will work with both the national project, and being involved in the EMA project, and the end-goal is to merge the two projects by incorporating the results and experiences from the national project in the European project.
The project has been discussed with stakeholders such as the pharmaceutical industry, representatives for pharmacies, patient organizations and the Swedish health care system. As Fonto, we are pleased to be able to support these important developments in healthcare.
Stay up to date with Fonto or experience it yourself.
Maarten van Vulpen
All from Maarten van VulpenRelated Articles
