Regulatory
Rapporteur
Write to the Editor at publications@topra.org
September 2025 | Vol. 22 | No. 8
EDITORIAL
Reimagining product information
Product information serves as a vital risk minimisation resource, providing both crucial data to healthcare professionals who prescribe medicines and also guidance to patients, to enhance their understanding of treatments.
In this issue, we delve into the fundamental role of product information and explore how technological advances are shaping its evolution to better support diverse patient needs.
By Ronnie Mundair of Pfizer and Kate Porch of Johnson & Johnson
FOCUS
Product information: An overview
Medicinal product information serves as the ‘public face’ of a product, containing key information to ensure its safe and effective use. This article gives an introduction to product information, how the content is created and managed, and the benefits of transitioning from current paper patient information leaflets to electronic product information labelling.
By Kate Porch of Johnson & Johnson and Ronnie Mundair of Pfizer
FOCUS
The EMA/NCA electronic product information initiative: Engagement, implementation and a vision for the future
In this interview, Juan García Burgos, Head of Public and Stakeholder Engagement at the European Medicines Agency (EMA), discusses the forthcoming implementation of the EMA/National Competent Authority electronic product information (ePI) initiative, how industry should prepare and the vision for the future of ePI.
By Ronnie Mundair of Pfizer and Kate Porch of Johnson & Johnson
FOCUS
Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals
The Belgium and Luxembourg e-PIL pilot was set up in 2018 to demonstrate the equivalence between the paper patient information leaflet (PIL) and the electronic version of this leaflet in providing information on the safe and effective use of medicines in the hospital setting. This article summarises the key findings of the pilot, gives a personal perspective from a hospital pharmacist and outlines next steps.
By Nathalie Lambot and Marie Vande Ginste of pharma.be
FOCUS
What could the future of labelling look like? The Gravitate-Health story
The future of digital intelligent labelling is evolving rapidly and progress towards electronic product information in the EU is being leveraged using international interoperability standards. This article introduces the Gravitate-Health digital lens (G-Lens®) concept to demonstrate the value of ePI and how it can lead to improved patient understanding and enhanced patient-health professional communication, giving examples of how labelling systems can become machine-readable, semantically richer and context-aware.
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, HL7 Europe
FOCUS
Translating real-world needs into digital medication tools: Good practices for co-creation with patients
It is essential that any digital health solutions capture the real-world needs of patients, including aspects relating to safety, usability, accessibility, data privacy, health literacy and digital literacy. This article shares some general representations of patient needs related to these aspects, as well as the framework that was used in the Innovative Medicines Initiative Gravitate-Health project and other projects to ensure the patient voice was captured in the development process.
By Yasemin Zeisl of the European Patients’ Forum (EPF)
FOCUS
Digital transformation of global regulatory affairs: Then, now and next
The combined advent of generative artificial intelligence (GenAI) and Health Level 7’s (HL7) next generation standard for Fast Healthcare Interoperability Resources (FHIR) has significantly accelerated the pace of regulatory innovation.
This article describes how pharmaceutical organisations can leverage this new paradigm to maximum effect and impact, using examples of faster document generation timelines, the transition to a simultaneous global submission model, and the delivery of personalised label content to patients on demand.
By Craig Anderson of Pfizer and Michael J Abernathy of Amgen
STANDALONE
Target Product Profile and Product Profile Characteristics for labelling during the drug development process
This article explores the evolving role of the target product profile (TPP) and product profile characteristics (PPC) in labelling development and the many benefits of global harmonisation efforts. It also provides an in-depth explanation of TPP and PPC concepts and uses relevant case studies to demonstrate the effective management of regulatory approvals across internal and external stakeholders.
By Sampath Kumar Belide, Vivek Sonwane, Arun Arya, Kirti Yadav, Vivek Tomar and Allison Gillespie, all of Syneos Health
Want to learn more?
Check out our CRED course: An overview of Regulatory Product Information.
This one-day workshop with expert speakers from health authorities and industry will give you an understanding of the strategic development of regulatory product information in Europe and the UK.
Attending the TOPRA Symposium?
Visit our HM8 session ‘ePI is on FHIR: Preparing for implementation’.
This session will focus on the regulatory implications and readiness strategies for the implementation of ePI based on the HL7 FHIR® standard.
Topics
- Digital health tools
- Electronic labelling (e-labelling)
- Electronic product information (ePI)
- European Medicines Agency (EMA)
- Generative artificial intelligence (AI)
- Gravitate-Health
- Health Level 7 Fast Health Interoperability Resources (HL7 FHIR)
- medicinal product information
- Patient engagement
- patient information leaflets
- Pharmaceuticals
- Product information (PI)
- product profile characteristics (PPC)
- target product profile (TPP)
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