Regulatory Affairs

Regulatory Rapporteur – September 2025

September 2025 – Contents

Reimagining product information

Product information: An overview

The EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future

Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals

What could the future of labelling look like? The Gravitate-Health story

Translating real-world needs into digital medication tools: Good practices for co-creation with patients

Digital transformation of global regulatory affairs: Then, now and next

Target product profile and product profile characteristics for labelling during drug development

September 2025 – Contents
Reimagining product information
Product information: An overview
The EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future
Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals
What could the future of labelling look like? The Gravitate-Health story
Translating real-world needs into digital medication tools: Good practices for co-creation with patients
Digital transformation of global regulatory affairs: Then, now and next
Target product profile and product profile characteristics for labelling during drug development

Industry News

Regulatory Rapporteur is back in PDF format
News of an exciting new development for Regulatory Rapporteur starting in October 2025.
MHRA cross-agency team outlines emerging considerations for the manufacture of personalised medicines
This industry news update shares the MHRA’s guidance for the manufacture of personalised medicines.
AI Airlock: Growing the future of artificial intelligence technology in healthcare
This industry news update is about the ongoing projects as a part of AI Airlock led by the MHRA.

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An update on how readers’ feedback is informing future developments for Regulatory Rapporteur.

EFPIA publishes guidance document to help support novel methodology submissions

This industry news update shares the EFPIA’s guidance document to help support the submission process for novel methodologies.

New Director appointed at the FDA’s Center for Drug Evaluation and Research

This industry news update discusses George Francis Tidmarsh, M.D., Ph.D., who has been appointed as Director of the Center for Drug Evaluation and Research.

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