The eLeaflet solution by myHealthbox is now supporting the ePI semi structured data format thus allowing full compatibility with the EMA digital information format for medicines and healthcare products information.

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What is the ePI

The EU ePI Common Standard is a standard developed and adopted by the EU Network Data Board on behalf of the European Medicines Regulatory Network. It can enable user-friendly, multilingual ePI linked to SPOR master data system.

The electronic Product Information (ePI) is an XML-based document markup standard approved by Health Level Seven (HL7 ) and adopted by the European Medicines Agency as a mechanism for exchanging product and facility information. Its adoption follows similar implementations carried out by Regulatory Agencies in the US, Australia, New Zealand, Singapore, Japan, Canada, Brazil, etc..

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Electronic product information (ePI) refers to the authorised, 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. In certain procedures, Annex II of the marketing authorisation (manufacturer(s) responsible for batch release, conditions and requirements of the marketing authorisation, other conditions or restrictions as applicable) is provided electronically in the ePI.

Transitioning to ePI offers advantages such as improved accessibility, searchability and multilingual capabilities.

What does this mean ?

Quite simply it is now possible to import EMA registered products in ePI format directly into the eLeaflet platform thus making the creation of an eLeaflet from a product with an ePI data file easy and fully automatic.

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Once imported into the eLeaflet platform the product information can be edited and reviewed, additional features like video, audio or digital Adverse Reactions Forms can be added. At the end of the process the eLeaflet can again be exported to ePI or to any of the supported formats like SPL, JPL, JSON, etc.

What is the difference between eLeaflet and ePI

First of all it is important to clarify that while sharing many similarities from both a data structure and design perspective the two formats solve 2 very different problems and originated from a different perspective into the broader problem of improving product information in the healthcare via digital solutions.

Both are semi-structured representations of data and specifically of product information data and both are targeted at healthcare products.

The ePI format is an XML-based data representation, in this respect it is not dissimilar to an xml-based Word format.

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Interoperability can be achieved between the two formats as our recent support for the ePI format within our eLeaflet solution demonstrates.

Now to the differences

The focus of ePI and main motivation for its adoption is on the improvement of the regulatory management cycle which comprises data editing, revision and approval management, languages support and terms standardization. The idea behind it was as a replacement for the MS Word/PDF format which was (and still is) widely used during the marketing authorization process to exchange information between the EMA and the MAH or producer.

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On the other hand the focus and main motivation behind the development of the eLeaflet solution is as a replacement and improvement of the paper leaflet that is usually part of a medicine's package. The idea is to improve the experience for the final users (both patients or HCPs), improve content accessibility and discovery and open the path to innovative functionalities.

While all the content definition features present in the ePI are also found in the eLeaflet, the latter allows for the definition of dynamic and interactive elements which are missing in the ePI design.

The eLeaflet is also designed for wide distribution and features like content security and anti-tampering, digital signatures and notarization are standard features in an eLeaflet; these are typically required in pharma-grade,GMP validated, solutions that are heavily regulated and accessed by millions of people.

Another important differentiator between the ePI format and the eLeaflet solution is that ePI is primarily a data exchange format used mainly in the EU for EMA regulated products (this may surely change in the future and we would like to see more countries and National Authorities adopting ePI or similar formats for nationally authorized products). Most companies that market their products outside of the EU will need to support different data formats or adapt to existing ones, for these the adoption of the ePI format represents just a partial solution.

More information about the eLeaflet solution from myHealthbox is available on the eLeaflet website

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