Reimagining product information

In this respect, it follows on perfectly from the July/August issue which focused on the growing levels of patient involvement in regulatory processes and the importance of patients being at the heart of everything regulatory professionals do.

This issue is designed to take readers on a journey from foundational knowledge to understanding forward-looking innovations in this rapidly changing area. The insights will allow you to not only grasp the efforts and perspectives of diverse stakeholders, but also to imagine a ‘better informed and confident patient of tomorrow’, a vision that may not be too far in the future.

We start with an overview of product information, describing what it is and how it is typically managed. This article, by Ronnie Mundair of Pfizer and Kate Porch of Johnson & Johnson, shares the basics for those not familiar with this important public-facing representation of the health authority approved dossier.

This sets the stage for the following articles that will, in turn, enable you to understand this rapidly evolving area of regulatory affairs and how it is taking advantage of the current digital era.

Our second article presents an interview with Juan García Burgos, Head of Public and Stakeholder Engagement at the European Medicines Agency (EMA), who shares electronic product information (ePI) developments at the EMA and national competent authority (NCA) level. With the formal EU ePI pilots concluding last summer, and the read-outs and next steps shared late in 2024, this is a very timely follow up on the latest progress of the initiative.

In our third article, Nathalie Lambot and Marie Vande Ginste of pharma.be provide a review of the Belgium and Luxembourg ePI pilot findings. This multi-year pilot, which required derogation from EU regulation, was conducted using hospital-only products, offering both patients and physicians access to the most up-to-date ePI version of the product information, and has been pivotal globally in understanding first-hand the impact of removing paper versions of patient information leaflets.

The reimagination of product information really begins in our fourth article by Giovanna Ferrari of Pfizer, Anne Moen of the University of Oslo, Ronnie Mundair of Pfizer, Craig Anderson of Pfizer, Catherine Chronaki of HL7 Europe and João Almeida of the University of Porto and HL7 Europe. It showcases the Gravitate-Health project, an Innovative Medicines Initiative public-private partnership, which assumes that ePI is available in its structured, interoperable content format. It demonstrates the potential value of ‘focused lens’ and how this could support patient understanding.

Our fifth article, by Yasemin Zeisl from the European Patients Forum, underscores the value of co-creation with patients when researching and developing digital medication tools such as Gravitate Health.

Concluding this issue’s collection of labelling-specific articles, Craig Anderson of Pfizer and Mike Abernathy of Amgen share an inspiring summary of the digital transformation of global regulatory affairs, which shows how technology continues to reshape our field.

For those new to the technical landscape, we’ve included a short summary below from Filippo Napoli, PMO Lead for HL7 Vulcan, on the basics of Fast Healthcare Interoperability Resources (FHIR), as this is referred to in several of the above articles.

Finally, to round off the issue, we feature an additional article by Sampath Kumar Belide, Vivek Sonwane, Arun Arya, Kirti Yadav, Vivek Tomar and Allison Gillespie, all at Syneos Health, on the use of target product profile (TPP) and product profile characteristics (PPC) for labelling during the drug development process, which greatly complements our product information focus.

As guest Issue Editors, we hope you enjoy this issue.