Medical TranslationsMedical Writing
The world is rapidly advancing towards the digitization of documents and processes, progressively transforming how information is created, shared, and archived. In line with this shift, the European Union aims to explore a new platform to record and catalogue digital medical information for authorized pharmaceuticals.
At the close of 2023, the Heads of Medicines Agencies (HMA), the European Commission, and the European Medicines Agency (EMA) jointly released electronic product information (ePI) for certain human medicines, marking the first-ever publication of such electronic information.
When it comes to pharmaceuticals products, the information must encompass various product characteristics, labelling details, and package inserts. These documents are mandatory accompaniments for any authorized medicinal product within the European Union, offering precise information regarding their usage and prescription.
Currently, they can be readily found online, within the websites of various regulatory authorities (in PDF format), as well as in print within the packaging of pharmaceuticals.
“Digital platforms open new possibilities to share this information electronically, keep it constantly updated and make it more accessible to end-users such as healthcare professionals and patients.” With these words, the European Commission introduces this new initiative, a pilot program designed to test a novel model for publishing digital medical information on pharmaceuticals.
Related:
- Introducing the European Medical Device Vigilance System
- WHO 2023 – Engaging Patients for Patient Safety
EU Platform and Digital Medical Information
As can be read on the EMA and European Commission websites: “Transitioning to ePI offers advantages such as improved accessibility, searchability and multilingual capabilities”. […] These ePIs were created following the EU ePI Common Standard, adopted by the European medicines regulatory network to provide a consistent structure throughout all Member States and ensure the information works across different e-health platforms”.
The initiative falls within the scope of the Pharmaceutical Strategy for Europe and involves 25 medicines.
The initial ePI publications encompass medicines evaluated by EMA or by national authorities in Denmark, the Netherlands, Spain, and Sweden. These have been drafted in English for centrally approved medicines and in the local language for nationally approved drugs.
Testing is currently underway to enable access in all languages of the Union.
For those seeking further details, these documents can be viewed on the Product Lifecycle Management Portal. More information can be found by consulting the dedicated pages on the websites of the European Commission and the EMA.
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