Hurra! Fonto has been selected as the XML editor of choice by the Swedish Medical Products Agency (Swedish MPA) for a national pilot study for pharmaceutical companies creating ePI.
Electronic Product Information (ePI)
ePI refers to the authorized, statutory product information for medicines (including the Summary of Product Characteristics, Package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in 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. Furthermore we saw an advantage in experience and knowledge from structuring of product information for medicinal products.Kim Sherwood
Senior Expert Product Information Assessor, Swedish Medical Products Agency
Swedish Medical Product Agency
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 (EMA)
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 health care.