How to avoid delays when submitting clinical trial application assessments The UK's new clinical trial regulations came into force on 28 April 2026, introducing a more flexible and risk-proportionate approach to clinical trial assessment. Sponsors now submit a single clinical …
As part of the shift towards a risk-proportionate regulatory framework, the MHRA’s Clinical Trials Unit ran a Route B substantial modifications pilot from 1 October 2025 to 31 March 2026 to test a new process to streamline the review of …
In six months’ time, on 28 April 2026, the most significant update to UK clinical trials regulations in two decades will come into force. This will be a pivotal moment for the evolving clinical trial landscape and marks a new …
September 2025: This blog provides information about the Route B substantial modifications and why you should sign up to take part in the pilot if you are eligible. We developed new clinical trial legislation in collaboration with the Health Research …
As the regulator, the safety of those volunteering to participate in clinical trials is our first priority, and our oversight of trial conduct is informed by trial sponsors efficiently notifying us of safety issues during the conduct of their trial. …
Innovation and supporting the research environment in the UK is a key priority for MHRA. But we know we can do more and be even better. You may have read a previous blog on this very topic (Spread the word …
...discussions, even before the non-clinical data is available if that is what will help your development plan. So do not wait, come and talk to us about your plans. We...
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