The European Medicines Agency (EMAfor its acronym in English) has highlighted the “success” of a pilot project to achieve the implementation of an electronic information system on the product of a medicine (ePI) in real regulatory procedures, as can be seen from a report that ensures that the European Union (EU) is ready for its introduction.
In depth
The text states that the EU can move towards its gradual application in regulatory proceduresfirst recognizing the need for further development, including additional functionality and integration with current IT systems.
Throughout 2025, this pilot project will continue to be developed, after which an attempt will be made to carry out an implementation gradualwhich will begin with voluntary adoption for centrally authorized products, to expand “progressively” to products authorized at national level depending on the readiness of Member States and available resources.
“Product information for a medicinal product includes your summary of product characteristics, labeling and leaflet. These documents accompany all medicines authorized in the EU and explain how they should be prescribed and used. All of them can be found, often as a document PDFon the websites of EU regulators, and a printed leaflet is also provided in the medicine box,” reads a statement from the agency.
More details
The introduction of product information in electronic format (ePI) compatible with digital platforms “opens new possibilities” so that patients and healthcare professionals, who will be able to access and interact with “vital and up-to-date” information about your medications.
This report has analyzed key indicators such as the time taken to create ePIs, the percentage of ePIs created and published successfully, the ease of use of IT tools and the usefulness of guidance materialswhich has facilitated the identification of recommendations on future work needed to enable the introduction of EPI into current regulatory processes.
To take into account
These recommendations also urge better guidance to support usersas well as business process updates to integrate ePI alongside existing practices with minimal disruption.
This is being developed by the EMA and the Directors of Medicines Agencies (HMA), supported by the EU funding program EU4Health, and in which the national authorities of Denmark have participated (DKMA), Netherlands (MEB), Spain (AEMPS) and Sweden (M.P.A.), along with the industry.
ePIs have been created following the EU Common EPI Standard, which provides a harmonized structure in all Member States which ensures that information works on the different e-health platforms for EU citizens. ePIs can be viewed on the Product Lifecycle Management Portal (PLM) and can be accessed through a public application programming interface.
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