Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Electronic product information - The global status quo and possible ePI advancements in the EU

Kristina Hoffmann (Abschlußjahr: 2021)

Summary
Language: English
With the ever-advancing digitalization, the topic of ePI for pharmaceuticals is increasingly shifting into focus. EU-wide taskforces are already being formed for a uniform implementation and the so-called key principles have been published by EMA in this context. Nevertheless, there is still a long way to go before ePI is implemented throughout the EU. In the meantime, some EU countries have started their own projects and initiatives to provide users access to the electronic information. The aim of this thesis is the elaboration of possible promotion strategies for an advanced ePI usage in the EU as well as its uniform implementation. The advantages of harmonized ePI are also analysed in more detail. European and global initiatives were taken into account for this discussion under the consideration of the key principles. Relevant developments in the EU, such as the increasing digitalization and the COVID-19 impact have also been considered.
Several approaches for the ePI advancement have been identified: As long as ePI use is not mandatory, MAHs, patients and HCPs should be encouraged to access ePI by enabling self-explanatory and user-friendly access options and simplified regulatory procedures. Linking ePI with eHealth systems and Telematics projects is another possibility to expand ePI application and pilot projects help to gain initial experience.
The most effective approach is a change of the corresponding EU law, which is currently planned for 2022. As a result, authorities, EMA and MAHs will be obliged to meet the requirements for ePI implementation within a statutory period and to make ePI available to users. Due to the large scope of the ePI initiative, it is advisable not only to enable flexible implementation, but also to provide EU guidelines for a uniform interpretation of the legal text and contribution to a consistent EU-wide implementation.
Pages: 45