Masterarbeit

Data Re-Use in Electronic Product Information: Technical Requirements and Potential for Reducing the Workload for Changes in the Product Information Text

Dr. Susanne Janku (2026)

Summary

Language: English

Digitalisation makes it possible to replace tasks that were traditionally performed manually with automated systems and machine-executed processes, making them faster and more reliable. Many manual tasks involved in processing changes to product information texts – described in this thesis using the example of changing the MAH's address – are labour-intensive and also a potential source of error. Digital transfor-mation in healthcare has been ongoing for several years. One of the activities in this area is the implementation of the ePI. Benefits expected from its introduction were described in the Key Principles in 2020. These include increased efficiency in the prepa-ration of text changes during the LCM, made possible by replacing manual tasks with automated processing. Automation is based on the availability of structured data and its re-use.

This thesis described the technical requirements for the machine-assisted automated re-use of data in the ePI and analysed its impact on regulatory efficiency during LCM. The focus was on the effort required by the MAH to implement text changes and its reduction enabled by the re-use of structured data in the ePI.

A prerequisite for the re-use of data is the interoperability of the systems involved, which is enabled by a common language and a common technical format used by sender and receiver. As one of the many use cases of the digital transformation, the ePI also has access to these technical prerequisites, which are currently being estab-lished in a phased process lasting several years:

The development of FHIR has enabled standardised digital communication that con-nects all systems involved in the healthcare sector. SPOR are the four sections of data management system providing structured data for pharmaceutical regulatory process-es. Data stored there also includes content that appears in the PI. PMS is the location within SPOR where individual data elements are linked together to identify a medicinal product. 30 of the 200 data elements characterising a product encode content of the PI. The implementation of SPOR and, in particular, PMS follows the ISO IDMP stand-ards, and the relevant rules have been published in the EU IG series. With PLM, a por-tal has been established through which structured data and the ePI can be transmit-ted, and templates for the ePI FHIR message file have been developed and published.

Pilot projects have been conducted. In the EU pilot project in 2024, the functions for submitting the ePI in PLM were tested. In Germany, the ‘diGItal’ pilot project is current-ly ongoing. It focuses in various use cases on the e-PL and is developing functions that allow users to access the e-PL, such as by searching for a specific MAH. In all activities to date, the exclusive focus has been on linking the ePI or e-PL to the product. To date, no functionalities for the automated change of PI content have been developed, nei-ther by the EMA nor in other pilot projects.

Possible reasons were discussed. One is that this functionality is not considered a high priority compared to other areas such as dealing with supply shortages. ePI is mainly seen as a way of providing patients and healthcare professionals with easy access to medicinal product information. However, when considering the entire process of modi-fying PI content, it becomes clear that even if data elements for content coding were included in the ePI FHIR file, manual editing of the file would still be necessary. The full potential of digitalisation would only be leveraged if the entire process could be fully automated, at least for the 30 data elements already linked to a product in PMS. In other words, if the step of submitting a content change would also automatically up-date the PI, rather than requiring two separate tasks.

As a possible solution the new concept of externalisation of data was discussed. It would work similarly to PMS, where data from different sources is linked and displayed as a data package that is updated each time it is retrieved. With the change to such an approach, the entire process of working on text changes could be fully automated. It might even be possible to automate further tasks, such as the translation into all EU official languages, for terms that have already been included in SPOR and are therefore validated. The responsibilities in such approach could be allocated in the same way as provided for the e-PL in the new legislation: the MAH is responsible for the content, and the regulatory authority for the linking.

An implementation in the near future seems unlikely, as the necessary technical and legal conditions would first have to be put in place. However, such a scenario would likely make it possible to fully leverage the potential of digitalisation for ePI.

Pages: 58

Annexes: 3, Pages: 3