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Regulatory Rapporteur October 2025 – Contents
Regulatory Rapporteur
October 2025 | Vol. 22 | No. 9
Write to the Editor at publications@topra.org
The October issue of Regulatory Rapporteur focuses on early drug development.
Contents:
- Focus: Central sourcing of authorised comparators and concomitant medications for multiregional clinical trials in accordance with ICH E17: CMC documentation requirements
- Focus: Navigating the landscape of paediatric clinical trials under US FDA guidelines
- Focus: Maximising regulatory success through early EMA engagement in drug development
- Focus: ICH Q1 guideline revisions to promote innovation and enable global patient access to high-quality medicines
- Focus: The use of prior knowledge and platform approaches in early vaccine development
- Standalone: Probiotics as nutraceuticals: Bridging science, health and regulation
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