Regulatory Affairs

Regulatory Rapporteur – October 2025

Regulatory Rapporteur October 2025 – Contents

From trials to approval: Regulatory strategies in early drug development

Central sourcing of authorised comparators and concomitant medications for multiregional clinical trials in accordance with ICH E17: CMC documentation requirements

Navigating the landscape of paediatric clinical trials under US FDA guidelines

Maximising regulatory success through early EMA engagement in drug development

ICH Q1 guideline revisions to promote innovation and enable global patient access to high-quality medicines

The use of prior knowledge and platform approaches in early vaccine development

Probiotics as nutraceuticals: Bridging science, health and regulation

Regulatory Rapporteur October 2025 – Contents
From trials to approval: Regulatory strategies in early drug development
Central sourcing of authorised comparators and concomitant medications for multiregional clinical trials in accordance with ICH E17: CMC documentation requirements
Navigating the landscape of paediatric clinical trials under US FDA guidelines
Maximising regulatory success through early EMA engagement in drug development
ICH Q1 guideline revisions to promote innovation and enable global patient access to high-quality medicines
The use of prior knowledge and platform approaches in early vaccine development
Probiotics as nutraceuticals: Bridging science, health and regulation

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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