Expert and public comments sought on ePI, open until 31/July/2021.

The EMA has opened a public consultation on the draft EU common standard for electronic product information or ePI. The consultation period is open until end of July 2021 so there is little time left to give feedback. Comments should be provided via an online form accessible here.

Consultation is sought on the following documents:

• ePI API (Application Programming Interface) specification and the associated ePI API service list;
• A FHIR (Fast Healthcare Interoperability Resources) XML (eXtensible Markup Language) template based on the QRD (Quality Review of Documents) template for human medicines.
• An instance of an ePI sample message is provided in XML and HTML (Hypertext Markup Language), along with a sample XSL (eXtensible Stylesheet Language) transformation.

All documents are available on GitHub here.

What is ePI?

EU Common Standard for electronic product information (ePI) is authorised, statutory product information for EU medicines including the summary of product characteristics or SmPC, labelling for outer and inner packing and the package leaflet in a semi-structured format. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print.

What is the ePI FHIR message template?

The objective of the ePI (FHIR) template is that it is to be used by template engines to transform PI information, in structured or semi-structured format to an ePI FHIR message.

Transformation of PI information (Source: EMA)

The resulting ePI XML message contains a FHIR resource, a Bundle of Bundles, each of which is a document having a composition, and supporting resources. The EMA will publish progress updates and details of stakeholder consultations and share these with patients, healthcare professionals, and the pharmaceutical industry.

Considerations on ePI

I believe it is important to state that the ePI initiative does not change the product information leaflet itself. It is merely a move away from a cumbersome paper-based system and an opportunity to streamline the processes of creating accurate product information leaflets on time in electronic format. The current mixture of structured and semi-structured data that we have seen in SPC documents for years does not support sophisticated data research and analysis. Maximum benefits of ePI would only be achieved via the use of electronic based package information leaflets. Updating or printing of the ever-changing leaflets would be a thing of the past, reducing the risk of having outdated package leaflets or even medicinal product recalls because of incorrect or outdated information. Professionals and the public would have instant access to the correct data online.

In summary

The ePI is well overdue, allowing the move away from outdated paper-based systems to modern electronic data management. With the envisaged use of FHIR for ePI, the path is set to modernise paper-based management of package leaflets. This more data driven approach is promising as long as it can be implemented European wide, not only at the EMA but also for national competent authorities. The benefits for professionals and the public include immediate access to the latest approved product information, availability of additional materials such as video and possible alerts informing about major leaflet updates.

The EMA has opened up a consultation period for professionals and the public alike to gather information on how best to support regulators, marketing authorisation holders, and the public using ePI, electronic product information. They need to know that the adopted Common Standard meets the needs of its future users, confirming they can access, view and disseminate product information in electronic format, ePI.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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