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
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EMA launches #HealthNotHype campaign
This industry news update shares the EMA’s new social media campaign to raise awareness for GLP-1 medicines.
MHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
NICE reviews health technology assessment to better support patients
This industry news update shares NICE’s plans to review how health technologies are evaluated.
More 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.
NICE increases access to SGLT-2 inhibitors medicines to help treat type 2 diabetes
This industry news update is on SGLT-2 inhibitors that NICE are expanding access for as an alternative treatment for type 2 diabetes.
RegRapPod − InConversation with Zohra Nasir and Aksa Rahman
InConversation talks careers with Zohra Nasir and Aksa Rahman
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